Pregnant Woman With Twins After 22 Weeks 0 Days of Gestation Clinical Trial
— JUMODAOfficial title:
National Prospective and Comparative Study on the Mode of Delivery of Twins
| Verified date | April 2016 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| Study type | Observational |
The purpose of this study is to determine the best obstetrical practices for twin delivery.
| Status | Completed |
| Enrollment | 8979 |
| Est. completion date | December 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - All patients delivering twins after 22 weeks and 0 days gestation in the participating maternities will be included in the study. Exclusion Criteria: - Patients who expressed opposition to the use of personal medical data or medical data from their children for this research will not be included in the study |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Robert Debré - APHP | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
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. Erratum in: N Engl J Med. 2013 Dec 12;369(24):2364. — View Citation
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. — View Citation
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. — View Citation
Smith GC. Perinatal death in twins. Author's reply on absolute risk. BMJ. 2007 Apr 14;334(7597):762. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Composite measure of intrapartum and neonatal death and serious morbidity of the second twin after 32 weeks 0 days of gestation | Intrapartum fetal death Neonatal mortality Apgar score lower than 4 at 5 minutes Neonatal trauma (fracture of long bones or skull, subdural hematoma, brachial plexus elongation, phrenic or facial paralysis, injury of the spinal cord Abnormal level of consciousness (coma, stupor, abnormal response to pain) Intubation longer than 24 hours within the first 72 hours of life, two or more episodes of neonatal convulsions in the first 72 hours of life Proved neonatal infection Bronchopulmonary dysplasia Necrotizing enterocolitis Intraventricular hemorrhage grade III or IV Periventricular leukomalacia. |
72 hours after birth | No |
| Secondary | 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 | No |
| Secondary | Composite measure of intrapartum and neonatal death and serious morbidity of the second twin after 32 weeks 0 days of gestation | 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 | No |
| Secondary | Composite measure of maternal death and serious morbidity after 32 weeks 0 days of gestation | Maternal death Severe postpartum hemorrhage (PPH) defined as PPH requiring transfusion, embolisation, surgery, intensive care unit Pulmonary embolism, deep venous thrombosis Cerebrovascular accident Postpartum psychosis Severe thrombopenia (<50 000) Severe anemia (<7g/dL) Renal failure (oliguria <500 mL/24h or creatinin>135 mmol/L) Maternal transfer in ICU Laparotomy Intraoperative injury to the bowel, ureter or bladder requiring repair Vulvar or perineal hematoma requiring evacuation Third and fourth degree perineal lacerations Systemic infection (positive blood culture or temperature > 38.5 °C on two or more occasions at least 24h apart) |
Weeks after birth and before hospital discharge | No |
| Secondary | Duration of neonatal hospitalisation of first twin | Duration between birth and hospital discharge | Weeks after birth and before hospital discharge | No |
| Secondary | Duration of neonatal hospitalisation of second twin | Duration between birth and hospital discharge | Weeks after birth and before hospital discharge | No |
| Secondary | Duration of maternal hospitalisation | Duration between delivery and hospital discharge | Weeks after birth and before hospital discharge | No |