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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to determine the best obstetrical practices for twin delivery.
Large retrospective cohort studies have reported increased neonatal death and morbidity associated with vaginal delivery in comparison with cesarean in twin pregnancies. A recent large international randomized trial, the Twin Birth Study (TBS), showed that planned cesarean does not significantly decrease or increase the risk of fetal or neonatal death or serious neonatal morbidity, as compared with planned vaginal delivery in twin pregnancy between 32 and 39 weeks of gestation with a first twin in cephalic presentation. However, neither these large retrospective cohort studies, because information regarding delivery management is lacking, nor the TBS, because of insufficient statistical power, can answer the question on how to manage vaginal twin deliveries.
The aim of the JUMODA study is first to confirm in France whether planned vaginal delivery is not associated with increased neonatal risks in comparison with planned caesarean as shown in the TBS and secondly to determine the best obstetrical practices in case of vaginal delivery.
Analysis will be performed according to the planned mode of delivery (planned cesarean or planned vaginal delivery) and stratified according to:
Twin rank: second or first twin
Gestational age: before 28 weeks of gestation, before 32 weeks, after 32 weeks, and after 35 weeks
In the whole population and in low risk populations.
For women delivering vaginally, analysis will be stratified according to:
Second twin presentation: vertex or non vertex
Obstetrical manoeuvres: none, internal cephalic version, external cephalic version, total breech extraction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregnant woman with twins | pregnant woman with twins |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite measure of intrapartum and neonatal death and serious morbidity of the second twin after 32 weeks 0 days of gestation |
| 72 hours after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Composite measure of intrapartum and neonatal death and serious morbidity of the first twin after 32 weeks 0 days of gestation | Composite measure of intrapartum and neonatal death and serious morbidity of the first twin after 32 weeks 0 days of gestation | Day 28 after birth |
| Composite measure of intrapartum and neonatal death and serious morbidity of the second twin after 32 weeks 0 days of gestation |
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Inclusion Criteria:
Exclusion Criteria:
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cohort of pregnant woman with twins or triplets or quadruples
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| Name | Affiliation | Role |
|---|---|---|
| François GOFFINET, MD, PhD | APHP, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Robert Debré - APHP | Paris | 75019 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24088091 | Background | Barrett JF, Hannah ME, Hutton EK, Willan AR, Allen AC, Armson BA, Gafni A, Joseph KS, Mason D, Ohlsson A, Ross S, Sanchez JJ, Asztalos EV; Twin Birth Study Collaborative Group. A randomized trial of planned cesarean or vaginal delivery for twin pregnancy. N Engl J Med. 2013 Oct 3;369(14):1295-305. doi: 10.1056/NEJMoa1214939. | |
| 17436454 |
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Composite measure of intrapartum and neonatal death and serious morbidity of the second twin after 32 weeks 0 days of gestation |
| Day 28 after birth |
| Composite measure of maternal death and serious morbidity after 32 weeks 0 days of gestation |
| Weeks after birth and before hospital discharge |
| Duration of neonatal hospitalisation of first twin | Duration between birth and hospital discharge | Weeks after birth and before hospital discharge |
| Duration of neonatal hospitalisation of second twin | Duration between birth and hospital discharge | Weeks after birth and before hospital discharge |
| Duration of maternal hospitalisation | Duration between delivery and hospital discharge | Weeks after birth and before hospital discharge |
| Smith GC. Perinatal death in twins. Author's reply on absolute risk. BMJ. 2007 Apr 14;334(7597):762. doi: 10.1136/bmj.39176.426424.3a. No abstract available. |
| 16045531 | Background | Smith GC, Shah I, White IR, Pell JP, Dobbie R. Mode of delivery and the risk of delivery-related perinatal death among twins at term: a retrospective cohort study of 8073 births. BJOG. 2005 Aug;112(8):1139-44. doi: 10.1111/j.1471-0528.2005.00631.x. |
| 12411358 | Background | Smith GC, Pell JP, Dobbie R. Birth order, gestational age, and risk of delivery related perinatal death in twins: retrospective cohort study. BMJ. 2002 Nov 2;325(7371):1004. doi: 10.1136/bmj.325.7371.1004. |
| 32109258 | Result | Korb D, Schmitz T, Seco A, Goffinet F, Deneux-Tharaux C; JUmeaux MODe d'Accouchement (JUMODA) study group and the Groupe de Recherche en Obstetrique et Gynecologie (GROG). Risk factors and high-risk subgroups of severe acute maternal morbidity in twin pregnancy: A population-based study. PLoS One. 2020 Feb 28;15(2):e0229612. doi: 10.1371/journal.pone.0229612. eCollection 2020. |
| 30095775 | Result | Korb D, Deneux-Tharaux C, Seco A, Goffinet F, Schmitz T; JUmeaux MODe d'Accouchement (JUMODA) study group and the Groupe de Recherche en Obstetrique et Gynecologie (GROG). Risk of Severe Acute Maternal Morbidity According to Planned Mode of Delivery in Twin Pregnancies. Obstet Gynecol. 2018 Sep;132(3):647-655. doi: 10.1097/AOG.0000000000002788. |
| 28486364 | Result | Schmitz T, Prunet C, Azria E, Bohec C, Bongain A, Chabanier P, D'Ercole C, Deruelle P, De Tayrac R, Dreyfus M, Dupont C, Gondry J, Graesslin O, Kayem G, Langer B, Marpeau L, Morel O, Parant O, Perrotin F, Pierre F, Poulain P, Riethmuller D, Rozenberg P, Rudigoz RC, Sagot P, Senat MV, Sentilhes L, Vayssiere C, Venditelli F, Verspyck E, Winer N, Lecomte-Raclet L, Ancel PY, Goffinet F; JUmeaux MODe d'Accouchement (JUMODA) Study Group and the Groupe de Recherche en Obstetrique et Gynecologie (GROG). Association Between Planned Cesarean Delivery and Neonatal Mortality and Morbidity in Twin Pregnancies. Obstet Gynecol. 2017 Jun;129(6):986-995. doi: 10.1097/AOG.0000000000002048. |