GROG

Objective

To use a cost-effectiveness study to assess the medical and economic impact of a new strategy for the screening and subsequent treatment of vaginal flora anomalies before the 20th week of gestation: molecular biology techniques (PCR for A. vaginae and G. vaginalis by point-of-care testing) will test self-collected vaginal samples in a population of pregnant women at low risk of preterm delivery.

Study design: open-label prospective randomized study

Study population: pregnant women at low risk of preterm delivery, before 20 WG

Intervention

2 groups with different management of their pregnancies. Pregnant women at low risk, regardless of any symptoms, will be randomized into 2 groups. The study will not include women at high risk of preterm delivery.

Innovative strategy (group A)

These women will undergo routine screening for bacterial vaginosis by analysis of their self-collected vaginal samples with this innovative technique; if the test is found to be positive, an appropriate treatment will be prescribed. The POC test will be considered positive if: A. vaginae is detected at a threshold > 105.copies per ml and/or G. vaginalis > 105 copies per ml. The women with vaginosis will be screened monthly for recurrences through 28 weeks, and recurrence will be treated.

Standard strategy (group B)

These women will not be routinely screened for bacterial vaginosis. This group will be followed according to the usual practices of the physicians seeing them.

Outcomes measures

Primary outcome: the differential cost-effectiveness ratio between the two groups, corresponding to the avoided costs of preterm deliveries before 37 weeks in the innovative treatment group.
Secondary outcomes: delivery before 26, 32, and 37 weeks.

Power /data analysis: 3405 subjects per group

Coordinator: Pr Florence Bretelle, Hôpital Nord, Marseille, France
Florence.BRETELLE@ap-hm.fr

Founding : PMRE 2013

Objective

To assess the efficacy of an electronic-personalized program including antenatal dietary and lifestyle during pregnancy to reduce the rate of labour procedures and interventions in comparison to standard care.

Study design: randomized controlled trial

Study population

Obese pregnant women (30 ≤ BMI < 40 kg/m2), age from 18 to 45 years old
Singleton pregnancy between 12+0 to 19+6 weeks of pregnancy
Having an email address, an Internet access and a cell phone

Intervention

The intervention will be presented as a comprehensive dietary and lifestyle intervention called « e-PPOP-ID » (electronic Personalized Programmed for Obesity in Pregnancy to Improve Delivery), including a combination of dietary, exercise, and behavioural strategies delivered by emails, text message on mobile phone and a web site. This program will be developed with the French start-up “Be Patient”.

Outcome measures

Primary endpoint: rate of obstetrical interventions during labour and delivery including Caesarean section and instrumental delivery (forceps and vacuum extractor).

Power/data analysis

The main objective of this study is to show the superiority of an electronic-personalized program over standard care to reduce the rate of delivery interventions (defined as caesarean section and instrumental (vacuum extractor and forceps) extractions) in obese pregnant patients. In the AUDIPOG database of the French maternities, the rate of delivery interventions is 50% among pregnant women with a BMI> 30 kg/m2. We believe that the electronic-personalized program could reduce this rate to 40% (i.e. a relative risk reduction of 20%). To detect this difference, using a 2-sided Chi-square test with an alpha risk of 5% and a power of 80%, we calculated that a total of 774 subjects (i.e. 387 subjects in each group) would be required.

Coordinator:
Philippe Deruelle. CHRU de Lille
philippe.deruelle@univ-lille2.fr

Founding: PHRCnational 2014

HIGHLOW : Low molecular weight heparin (LMWH) to prevent recurrent venous-thromboembolism in pregnancy: a randomized controlled international multicenter trial of two doses

Objective

To compare the efficacy in terms of reduction of thromboembolic events at 6 weeks postpartum (PP) of a higher weight-adjusted LMWH dose called « intermediate dose » to a fixed low dose in pregnant women with a past history of venous thromboembolism.

Study design

Randomized controlled trial.

Study population

Pregnancy < 14 weeks of gestation, confirmed by urine or blood test
Previous objectively confirmed VTE (lower or upper-extremity DVT, cerebral venous sinus thrombosis, pelvic vein thrombosis or pulmonary embolism) either unprovoked in the presence of use of oral contraceptives or estrogen/progestogen use, or related to pregnancy or the postpartum period, or minor risk factors (e.g. long distance travel, minor trauma).

Intervention

To compare to dose regimens of LMWH, low dose group (Enoxaparin 4000 UI once a day if BW< 100 Kg or Enoxaparin 6000 UI once a day if BW> 100 Kg) versus intermediate dose group (Enoxaparin 6000 UI once a day if BW< 50Kg, Enoxaparin 8000 UI once a day if 50 < BW < 70 Kg, Enoxaparin 10000 UI once a day if 70<bw< 100= » » kg,= » » enoxaparin= » » 12000= » » ui= » » once= » » a= » » day= » » if= » » bw= » »> 100 Kg) starting before 14 WG.

Outcome measure

Occurrence of a symptomatic thromboembolic event in pregnancy and until 6 weeks postpartum objectively confirmed.

Power/data analysis

We expect an incidence of 4 to 5% of recurrent VTE during pregnancy in the lowdose group. To demonstrate a 65% reduction in the risk of VTE in the intermediate group, a sample size of a total of 859 to 1074 women is needed (power= 80%, alpha risk=5%).

Coordinateur :
Pr Céline Chauleur, CHU de Saint-Etienne, France
celine.chauleur@chu-st-etienne.fr

Financement : PHRCnational 2014

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HPAG: Effect of serial plotting of customized fundal height charts on identification and outcomes of small for gestational age infants

Objective

To test the effectiveness of the serial plotting of symphisis fundal height (SFH) and estimated fetal weight (EFW) measures on customized percentile charts supported by provider training, versus standard antenatal care, to improve the detection of fetal growth restriction (FGR). Our aim is to double rates of antenatal detection from 20 to 40% among small for gestational age (SGA) infants, defined as a birthweight under the 10th percentile for GA.

Study design

Randomized cluster trial.

Study population

Women with low and high-risk singletons pregnancies, who receive antenatal care in participating maternity units starting at a minimum of 28 weeks GA, and deliver in the unit.

Intervention

The intervention consists only in the standardization of current practices. Clinicians in the intervention maternity units will follow a standardized protocol, and will be asked to measure SFH at each antenatal appointment, collect EFW from the 3rd trimester US, report these values on the chart, and monitor fetal growth according to the protocol guidelines. Practices will remain unchanged in the control group.

Outcome measures

Primary outcome measure: Detection of FGR during pregnancy, defined as:
– The mention of suspected growth restriction in medical charts
– And either at least one referral for additional US for growth monitoring
– And/or a provider indicated delivery for FGR among SGA births, defined as infants with a birthweight below the 10th centile of French customized fetal weight reference (CFWR).
Secondary outcome measures:
– Perinatal outcomes: late fetal death, Apgar score<7 at 5 min, pH<7, resuscitation, severe FGR, admission to a neonatal unit, intraventricular hemorrhage, encephalopathy, death
– Rate of false positives defined as suspected FGR among non-SGA births according to the CFWR
– Modes of onset of labor and of delivery
– Resource use and costs

Power/data analysis

Assuming a doubling of the detection rate from 20 to 40% among SGA births with power 80%, a significance of 95% and a number of 16 clusters, 376 SGA (24 per cluster) are required, however the corresponding sample of non-SGA births (3384) would not allow for an accurate estimation of the FP rate under the assumption of 2.1% of FP. We will finally include a total sample of 10 000 births (625 per cluster): 1000 SGA, 300 severe SGA, 9000 non-SGA including 189 FP. Assuming that half of births in level III centers are eligible for the trial, and that the annual total number of births in the 16 maternity units is 51 200, the recruitment will take around 6 months.

Coordinator:
Anne Ego. CHU de Grenoble, Grenoble
aego@chu-grenoble.fr

Founding: PHRCnational 2014

Objective

To test that oral Glyburide is not inferior to subcutaneous insulin for the occurrence of perinatal complications in the treatment of pregnant women developing gestational diabetes requiring treatment other than dietary.

Study design

Randomized multicenter controlled non inferiority trial.

Study population

Women between 18 and 45 years, with a singleton pregnancy and gestational diabetes diagnosed between 24 and 34 weeks of gestation, that have not achieved glycemic goal fasting glucose < 0.95g/l and post prandial glucose 2h < 1.20g/l despite a complete dietary management.

Intervention

Treatment with 5 to 20 mg/day of Glyburide versus subcutaneous insulin.

Primary outcome

Composite criteria including neonatal complications: macrosomia and birth weight ≥ 90 th centile for gestational age, neonatal hypoglycemia, and neonatal hyperbilirubinemia.

Power/data analysis

The primary outcome rate is estimated 18% in the insulin group. With a 80% power and 5% significance, 450 subjects per group are needed to show that treatment with Glibenclamide is not considered inferior to treatment with insulin if the frequency of the composite criteria does not exceed 25% with Glibenclamide.

Coordinator: Pr MV Senat, Hôpital Bicêtre, Le Kremlin-Bicêtre, France,
marie-victoire.senat@bct.aphp.fr

Founding: PHRC national

JUMODA: National prospective and comparative study on the mode of delivery of twins

Objective

To compare the neonatal mortality and morbidity according to the planned mode of delivery and to identify the practices associated with poor neonatal outcomes.

Study design

National prospective study

Intervention: comparison of the neonatal morbidity and mortality rates in the planned caesarean and planned vaginal delivery groups.

Study population

All patients with a twin pregnancy delivering after 22 weeks of gestation in the 174 participating centres.

Outcome measure:
The same composite measure of neonatal morbidity and mortality as in the Twin Birth Study.

Sample size

Assuming a neonatal morbidity rate of 2% after 32 weeks of gestation in the planned vaginal delivery group and 30% of planned cesarean deliveries, 6152 women will have to be included to demonstrate a 50% decrease of the neonatal morbidity rate from 2% to 1% associated with a planned cesarean delivery (power 80%, alpha 5%). This study will have enough power to demonstrate, associated with internal cephalic version in comparison with pushing efforts in case of cephalic presenting second twin, an 80% reduction in the rate of cesarean for second twin delivery.

Coordinator: Thomas Schmitz
thomas;schmitz@rdb.aphp.fr

Funding: PHRC-nat 2012

LUSTrial: Lower Uterine Segment Trial

Objective

To evaluate the efficacy of the ultrasonographic measurement of lower uterine segment associated with a decision rule in order to reduce the fetal and maternal mortality and severe morbidity in the management of women with a history of one caesarean delivery.

Study design

Open-label, multicenter, randomized controlled trial.

Study population

– age ≥ 18 years old
– singleton pregnancy in cephalic presentation
– gestational age at between 36 and 38 weeks of gestation
– history of one previous caesarean section
– prior low transverse incision

Exclusion criteria

– indication for elective repeat caesarean delivery (ERCD) or patient refusal for trial of labor (TOL)
– patient presenting a placenta previa

Intervention

Between 36 and 38 weeks, the patients will be randomized into two groups:
– A study group in which ultrasonographic measurement of the lower uterine segment is systematically performed. The referring obstetrician and the patient are informed of the result of the measurement and thus may use it in deciding on mode of delivery.
– And a control group in which ultrasonographic measurement of the lower uterine segment is not performed. The mode of delivery is decided according to the routine practice.

In the study group, using the proposed cut-off values of > 3.5 mm for the full thickness:
– above the cut-off value, the patient will be encouraged to accept a TOL
– equal or below the cut-off value, the patient will be encouraged to accept an ERCD

Outcome measure

Composite primary criterion including:
– Maternal death
– Maternal morbidity: uterine rupture rate, uterine dehiscence, hysterectomy, thromboembolic events, transfusion, endometritis
– Antepartum stillbirth, intrapartum stillbirth, neonatal death.
– Neonatal morbidity: Hypoxic ischemic encephalopathy, 5-Minute Apgar score ≤5, Umbilical-artery blood pH ≤ 70.

Sample size

Assuming that the use of the ultrasonographic measurement of lower uterine segment will reduce the fetal and maternal mortality and morbidity to a rate similar to that of the elective cesarean section, 1471 patients in each group are necessary in order to demonstrate a reduction of two third in the composite criterion rate, i.e. from 6.41% in the control group to 4.07% in the experimental group, with a power of 80% and a two-sided type I error rate of 5%.

Coordinator: Pr Patrick Rozenberg
prozenberg@chi-poissy-st-germain.fr

NAITRE: preNAtal care in deprIvaTed enviRonnEment

Objective

To assesse the impact of financial incentives on pregnancy outcomes in under-privileged pregnant women.

Study design

Pragmatic, cluster-randomized, parallel arms clinical trial.

Study population

– pregnant women
– older than 18
– first consultation before the 26th week of amenorrhea
– beneficiary of the Universal medical coverage or complementary universal medical coverage
– non-opposed to participate into this study

Intervention

A pre-paid bank card, conditioned to the adherence to scheduled pregnancy follow-up, according to standard guidelines, will be given to pregnant women in the intervention group.

Outcome measure

A composite of maternal and perinatal morbidity

Power data analysis

Planned number of participants: 4000 pregnant women, divided in 2 groups of 2000, with administrative district as the unit of randomization.
This study will first involve 9 level 3 maternities (in alphabetical order, Besançon, Brest, Dijon, Lille, Le Kremlin-Bicêtre, Marseille Hôpital Nord, Robert Debré, Saint-Etienne and Tours) and be secondarly expanded to about 30 additional level 1 to 3 maternities.

Coordinator: Pr Marc Bardou, CHU Dijon
marc.bardou@chu-dijon.fr

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PACCRETA: clinical situations at high risk of placenta ACCRETA/percreta: impact of diagnostic methods and management on maternal morbidity

Objective

The primary objectives are to identify individual risk factors, as well as factors associated with types of management and with the healthcare facilities for postpartum hemorrhage. Secondary objectives are to (i) determine the prevalence of placenta accreta among women at risk; (ii) assess the predictive value of ultrasound and MRI for the diagnosis of placenta accreta in this population; (iii) evaluate psychological impact and physical complications; and (iv) report maternal physical complications during the year after delivery.

Study design

Population-based prospective observational study of pregnant women with a placenta inserted at a uterine scar in 182 centers in eight French regions, with 270 000 deliveries annually.

Study population

All pregnant women with a uterine scar and anterior placenta previa (defined as the “women at risk”) and giving birth in one of the 182 participating maternity units over a two-year period
Intervention: none

Outcome measures

The primary outcome measure is severe PPH, defined as a PPH involving transfusion _4 units of packed red blood cells.
The secondary outcome measures are as follows:
– Incidence of placenta accreta or percreta in patients with a uterine scar and placenta previa
– Diagnostic value for placenta accreta or percreta of ultrasound and of MRI
– Hysterectomy rates
– Psychological repercussions and physical complications at six and 12 months

Power/data analysis

The total number of deliveries expected in the study is 540 000 women. Of these, 11% will have had a previous cesarean section. The rates of placenta previa usually reported in the literature are in the order of 0.8–1.5%. With a hypothesis of 1%, 620 women with a previous cesarean section and an anterior placenta previa are expected during the study. Of them, 10–40% will have a placenta accreta. This assessment corresponds to a placenta accreta rate of 1/4700, that is, among the lowest range of prevalence rates reported in the literature.

Coordinator:
Pr Gilles Kayem, AP-HP, Hôpital Trousseau, Paris
gkayem@gmail.com

Founding: PHRCinterrégional 2012

PESSARONE: Pessary to prevent prematurity in twins in case of short cervix

Objective

To evaluate the efficacy of cervical pessary to reduce paediatric mortality and morbidity in asymptomatic short cervix twin pregnancies.

Study design: prospective multicentre open-label randomized, controlled trial.

Study population

– asymptomatic twin pregnancies
– between 16 and 24 weeks of gestation
– cervical length < 35 mm
– vaginal swabs for bacteriological analysis < 72 hours
– age > 18 years
Intervention: women will be assigned either to the cervical pessary group or control group.

Outcome measures

The primary outcome measure is a composite of perinatal death, respiratory distress syndrome requiring ventilation more than 24 hours, bronchopulmonary dysplasia, intraventricular hemorrhage, periventricular leukomalacia, necroziting enterocolitis grade 2 and higher, culture proven sepsis, and retinopathy of prematurity.

Power/data analysis

Assuming a 25% rate for the primary outcome in the control group and an estimated rate of lost-to-follow up of 5%, 324 women will have to be recruited, 162 in each group, to demonstrate a reduction in perinatal morbidity from 25% to 12% associated with the use of the cervical pessary (power 80%, alpha 5%).

Coordinator: Pr Christophe Vayssière, CHU Toulouse
cvayssiere@club-internet.fr

Founding: PHRC-nat 2013

Projet de soutien aux techniques innovantes et coûteuses (STIC) SAFE 21

Le dépistage combiné de la trisomie 21 au premier trimestre est proposé à toutes les femmes enceintes. Ce dépistage fait apparaître, dans 3 à 5% des cas environ, un risque de trisomie 21 supérieur à 1/250. Les recommandations médicales actuelles prévoient alors de proposer un diagnostic prénatal (DPN) par biopsie de trophoblaste entre 11 et 14 SA ou par amniocentèse après 15 SA. Ce prélèvement invasif permet d’établir le caryotype fœtal et ainsi d’exclure formellement une trisomie 21 et d’autres anomalies chromosomiques moins fréquentes. Toutefois, sur l’ensemble des femmes « à risque supérieur à 1/250 », le caryotype fœtal est normal dans environ 95% des cas et il existe un risque faible de complications, en particulier de fausse couche (dans environ 0.5-1% des cas) dans les suites du prélèvement invasif.
Les progrès techniques récents rendent possible l’étude de l’ADN fœtal qui circule dans le sang maternel dès les premières semaines de grossesse (Dépistage prénatal avancé non invasif – DPANI) et ainsi de détecter plus de 99% des trisomies 21. Ce DPANI permettrait d’éviter à une majorité des femmes à risque de recourir au prélèvement invasif. Le DPANI a aujourd’hui des performances stabilisées mais n’est toutefois pas concluant dans 2-5% des cas. Il n’y a pas à ce jour d’évaluation de l’impact clinique du DPANI (en particulier réduction du taux de fausses couches), de la préférence des femmes (entre un diagnostic de certitude avec un risque faible de complication, et une approche sans risque pour la grossesse avec un faible risque d’échec technique et un risque très faible de faux négatif) et de son impact médico-économique (réduction du taux de prélèvements invasifs sans modification du suivi ultérieur de la grossesse).

Le projet STIC SAFE 21 a pour but d’évaluer et de comparer le DPN et le DPANI chez les femmes à risque de trisomie 21.

Peuvent être incluses dans le protocole les patientes

– âgées de plus de 18 ans ayant une grossesse mono fœtale ;
– ayant un risque élevé de trisomie 21 estimé sur la base du dépistage combiné ou séquentiel intégré (compris entre 1/5 et 1/250) ;
– à un âge gestationnel compris entre 11 et 18 SA ;
– affiliées à un régime de Sécurité sociale et signant le consentement éclairé.

Ne seront pas incluses dans le protocole les patientes :
– dont le risque combiné ou séquentiel intégré est en dehors de la plage d’inclusion ;
– avec une mesure de clarté nucale fœtale > 3 mm et/ou une mesure de PAPP-A et/ou de βHCG < 0.3 MoM ou > 5 MoM ;
– dont le fœtus présente une anomalie morphologique patente à l’échographie ;
– ayant une grossesse multiple ou la notion de « jumeau évanescent » ;
– refusant de signer le consentement éclairé.

Dans le protocole SAFE 21 : (i) une information détaillée sur le DPN et le DPANI est donnée à toutes les patientes et leurs préférences au regard des différents tests sont colligées pour analyse. (ii) Les patientes qui le souhaitent peuvent ensuite poursuivre leur participation par une randomisation entre DPN et DPANI. Les deux approches sont prises en charge financièrement à 100%.
Si la patiente bénéficie d’un DPN, elle est prise en charge selon le parcours de soin usuel, le prélèvement invasif et le caryotype sont réalisés selon les procédures habituelles. C’est également la prise en charge proposée aux femmes ne souhaitant pas être randomisées. Comme c’est déjà le cas actuellement, la patiente a toute autonomie pour décider de ne pas réaliser de prélèvement invasif, même après randomisation
Si la patiente bénéficie d’un DPANI, un prélèvement de sang maternel est réalisé et adressé au centre d’analyse dédié à l’étude SAFE 21. Le résultat de cette analyse est donné sous 3 semaines. Trois types de résultats sont possibles :

1. Le résultat de cette prise de sang est normal (90 à 95% des cas). Sur la base des études existantes, il est estimé que l’on peut finalement diviser le risque initial de trisomie 21 par 50, voire plus. C’est-à-dire que si le risque était de 1/50, il sera réévalué à moins de 1/2500. Les patientes pourront ainsi être rassurées puisque finalement le risque de trisomie 21 bien que jamais nul, sera extrêmement faible. Si ce résultat ne suffit par à rassurer la patiente, il est possible de recourir à un prélèvement invasif. Dans le cas d’une anomalie ou d’une suspicion d’anomalie lors du suivi échographique de la grossesse, il sera également possible de réaliser à tout moment un prélèvement invasif pour caryotype.

2. Si le résultat de la prise de sang revient anormal, il sera proposé de réaliser rapidement une amniocentèse qui confirmera dans presque tous les cas la présence d’une trisomie 21 fœtale.

3. Enfin, si le résultat de la prise de sang est ininterprétable (2 à 5% des cas), il sera proposé à la patiente de réaliser un DPN par amniocentèse.
Le projet STIC SAFE 21 vise à favoriser la diffusion rapide et harmonieuse des techniques de Dépistage prénatal avancé non invasif (DPANI) en optimisant l’information des femmes. Le projet STIC SAFE 21 permettra dans le même temps d’évaluer le DPANI sur le plan médical, psychologique, sociologique et économique en comparaison avec le diagnostic prénatal classique actuellement proposé, tout en respectant l’autonomie des femmes. Afin de pouvoir améliorer et faire rapidement évoluer les recommandations et politiques de Santé, il est nécessaire que les femmes puissent être incluses dans le projet STIC SAFE 21.

Pour tout renseignement ou inclusion : stic.safe21@gmail.com

Results in :

Induction of labour versus expectant management for large-for-date fetuses: a randomised controlled trial.Induction of labour versus expectant management for large-for-date fetuses: a randomised controlled trial.
Boulvain M, Senat MV, Perrotin F, Winer N, Beucher G, Subtil D, Bretelle F, Azria E, Hejaiej D, Vendittelli F, Capelle M, Langer B, Matis R, Connan L, Gillard P, Kirkpatrick C, Ceysens G, Faron G, Irion O, Rozenberg P; Groupe de recherche en obstétrique et gynécologie (GROG).
Lancet. 2015 Apr 8. pii: S0140-6736(14)61904-8.

Coordinator: Michel Boulvain (Switzerland) and Patrick Rozenberg (France)

Results in :

Cervical length in asymptomatic twin pregnancies: prospective multicenter comparison of predictive indicators.
Levêque C, Vayssière C, Favre R, Audibert F, Chauvet MP, Maillard F, Elhinger V, Arnaud C; Research group in obstetrics and gynecology (GROG).
J Matern Fetal Neonatal Med. 2015 Jan;28(1):37-40. doi: 10.3109/14767058.2014.900038.

Cervical assessment at 22 and 27 weeks for the prediction of spontaneous birth before 34 weeks in twin pregnancies: is transvaginal sonography more accurate than digital examination?
Vayssière C, Favre R, Audibert F, Chauvet MP, Gaucherand P, Tardif D, Grangé G, Novoa A, Descamps P, Perdu M, Andrini E, Janse-Marec J, Maillard F, Nisand I; Research group in obstetrics and gynecology (GROG).
Ultrasound Obstet Gynecol. 2005 Dec;26(7):707-12.

Cervical length and funneling at 22 and 27 weeks to predict spontaneous birth before 32 weeks in twin pregnancies: a French prospective multicenter study.
Vayssière C, Favre R, Audibert F, Chauvet MP, Gaucherand P, Tardif D, Grangé G, Novoa A, Descamps P, Perdu M, Andrini E, Janse-Marec J, Maillard F, Nisand I.
Am J Obstet Gynecol. 2002 Dec;187(6):1596-604.

Coordinator: Christophe Vayssière

Results in :

Outpatient cervical ripening by nitric oxide donors for prolonged pregnancy: a randomized controlled trial.
Schmitz T, Fuchs F, Closset E, Rozenberg P, Winer N, Perrotin F, Verspyck E, Azria E, Carbonne B, Lepercq J, Maillard F, Goffinet F; Groupe de recherche en obstétrique et gynécologie (GROG).
Obstet Gynecol. 2014 Dec;124(6):1089-97. doi: 10.1097/AOG.0000000000000544.

Coordinator: Thomas Schmitz

Results in :

Prevention of preterm delivery after successful tocolysis in preterm labor by 17 alpha-hydroxyprogesterone caproate: a randomized controlled trial.
Rozenberg P, Chauveaud A, Deruelle P, Capelle M, Winer N, Desbrière R, Perrotin F, Bohec C, Connan L, Vayssière C, Langer B, Mantel A, Azimi S, Porcher R, Azria E; Groupe de recherche en obstétrique et gynécologie.
Am J Obstet Gynecol. 2012 Mar; 206(3):206.e1-9. doi: 10.1016/j.ajog.2011.12.026. Epub 2011 Dec 27.

Coordinator: Patrick Rozenberg

Results in :

Prevention of preterm delivery by 17 alpha-hydroxyprogesterone caproate in asymptomatic twin pregnancies with a short cervix: a randomized controlled trial.
Senat MV, Porcher R, Winer N, Vayssière C, Deruelle P, Capelle M, Bretelle F, Perrotin F, Laurent Y, Connan L, Langer B, Mantel A, Azimi S, Rozenberg P; Groupe de recherche en obstétrique et gynécologie (GROG).
Am J Obstet Gynecol. 2013 Mar; 208(3):194.e1-8. doi: 10.1016/j.ajog.2013.01.032.

Coordinator: Patrick Rozenberg

Results in :

17 alpha-hydroxyprogesterone caproate does not prolong pregnancy or reduce the rate of preterm birth in women at high risk for preterm delivery and a short cervix: a randomized controlled trial.
Winer N, Bretelle F, Senat MV, Bohec C, Deruelle P, Perrotin F, Connan L, Vayssière C, Langer B, Capelle M, Azimi S, Porcher R, Rozenberg P ; Groupe de recherche en obstétrique et gynécologie (GROG).
Am J Obstet Gynecol. 2014 Oct 30. pii: S0002-9378(14)02152-8. doi: 10.1016/j.ajog.2014.10.1097. [Epub ahead of print]

Coordinator: Patrick Rozenberg

Results in :

High Atopobium vaginae and Gardnerella vaginalis Vaginal Loads Are Associated With Preterm Birth.
Bretelle F, Rozenberg P, Pascal A, Favre R, Bohec C, Loundou A, Senat MV, Aissi G, Lesavre N, Brunet J, Heckenroth H, Luton D, Raoult D, Fenollar F ; Groupe de recherche en obstétrique et gynécologie (GROG).
Clin Infect Dis. 2015 Mar 15;60(6):860-7. doi: 10.1093/cid/ciu966.

Coordinator: Florence Bretelle

PROSPERE Randomized Controlled Trial: Laparoscopic sacropexy versus vaginal mesh for cystocele POP repair

Objective

To compare the morbidity of laparoscopic sacropexy with vaginal mesh for cystocele repair.

Study design

Multicenter prospective randomized controlled trial.

Study population

– patients aged 45 to 75 years old;
– cystocele ≥ stage 2 of the POP-Q classification (isolated or not);
– lack of previous surgical POP repair.

Intervention: women will be randomized in two parallel groups for either laparoscopic sacroplexy or vaginal mesh

Outcome measures

The primary endpoint will be the rate of surgical complications ≥ Grade 2 of the Clavien – Dindo classification at one year follow-up. The secondary aims are to compare the functional results in the medium term (sexuality, urinary and bowel symptoms, pain), the impact on quality of life as well as anatomical results.

Power/data analysis

The estimated number of subjects required is based on the primary endpoint in trial. Based on an expected difference of 12% with a base rate of 7% for the sacropexy (usually reported in the literature rate) and a tolerable maximum rate of 19% for vaginal mesh, and taking alpha = 5% beta = 20% bilaterally, we obtain n = 119 per group (approximate method). Taking into account a rate of 10% per group lost to follow-up at one year, we need to include 131 patients per group, 262 patients in total.

Coordinator: Dr Jean-Philippe LUCOT, Hôpital Jeanne de Flandre, CHRU de Lille
jean-philippe.lucot@chru-lille.fr

Funding: PHRC-Nat 2011

PROSPERE-4: Randomized controlled trial comparing laparoscopic sacropexy and vaginal mesh surgery for women cystocele repair: Functional and anatomical results at four years follow-up

Objective

To compare the functional outcome of laparoscopic sacrocolpopexy and vaginal mesh surgery in the treatment of symptomatic exteriorised cystocele up to 4 years after surgery.

Study design

Prospective Cohort study: Long term follow-up study of patients included in a randomized controlled individual opened multicenter trial comparing two surgical techniques with one-year follow-up.

Study population

All the patients included in the PROSPERE study will be included in the PROSPERE-4 study. The inclusion criterias for the PROSPERE study are:
– Women aged 45 to 75 years
– Patient undergoing surgey for a cystocele greater than or equal to stage 2 of the International Classification POP-Q, isolated or associated with other elements of prolapse
There are no exclusion criteria for the PROSPERE-4 study.

Intervention

Women were randomized in two parallel groups for either laparoscopic sacroplexy or vaginal mesh.

Outcome measures

The functional outcome of the intervention will be evaluated using the symptom score calculated using the PFDI-20. The secondary objectives are: (1) comparison of the two techniques for anatomical results based on the clinical evaluation of patients with POP-Q. (2) overall quality of life assessment and expectations of patients. (3) the comparison of the two techniques for the long-term safety. The evaluation will focus on the adverse effects of long-term sexual and genital symptoms, urinary and digestive functional symptoms, and chronic pelvic pain. (4) the comparison of the improvement of the functional outcome assessed by PFDI-20 questionnaire (matched-analysis before versus after).

Power/data analysis

262 patients were included in the PROSPERE study. The power calculation is based on the confidence interval of the effect size. A maximum rate of 20% lost to follow-up gives 105 subjects per group. The published values of postoperative PFDI-20 range from 21.1 ± 23.6 to 61.0 ± 55.3. Taking a minimum score of 25 ± 25 and a the maximum score of 62 ± 62 we obtain a minimum effect size (alpha risk 5%) in bilateral of 0.27, leading to a difference of 8 unit.
Timetable: 3 years (after the initial period of 1 year in the PROSPERE study)

Coordinator: Dr Jean-Philippe LUCOT, Hôpital Jeanne de Flandre, CHRU de Lille
jean-philippe.lucot@chru-lille.fr

Funding: PHRC-Nat 2013

Results in:

Medical treatment of ectopic pregnancies: a randomized clinical trial comparing methotrexate-mifepristone and methotrexate-placebo.
Rozenberg P, Chevret S, Camus E, de Tayrac R, Garbin O, de Poncheville L, Coiffic J, Lucot JP, Le Goueff F, Tardif D, Allouche C, Fernandez H; GROG.
Hum Reprod. 2003 Sep;18(9):1802-8.

Coordinator: Patrick Rozenberg

Results in:

Fertility after ectopic pregnancy: the DEMETER randomized trial.

Fernandez H,Capmas P, Lucot JP, Resch B, Panel P, Bouyer J; GROG.

Hum Reprod. 2013 May;28(5):1247-53. doi: 10.1093/humrep/det037.

Coordinator: Hervé Fernandez