Twin Pregnancy
Conditions
Keywords
pessary, extending pregnancy
Brief summary
Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea
Detailed description
Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea To show that the use of pessary makes it possible to lengthen the duration of the pregnancy of at least 10 days in patients with a twin pregnancy and a uterine collar length \< = 25 mm measured by echography between 20 and 28 SA compared to the group controls.
Interventions
DEVICESilicon ring positioned in the vagina, around the cervix
Silicon ring positioned in the vagina, around the cervix
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years (legal majority in France) * Inclusion pessary positioning before 28 WG * Twin pregnancies, mono or dichorionic, diamniotic * Transvaginal cervical length ( 25mm between 20 et 28 WG * Intact membranes * No signs of infection (negative urine culture, CRP \<10mg/l , blood white cell count \<15000/ml) * Patient accepting follow-up * Covered by health insurance for France
Exclusion criteria
* Cerclage * No more cervix * Chorioamnionitis * Abnormal CTG * Placenta praevia * Abruptio * Bleeding * PROM * Singleton or multiple \>2 * Monochorionic monoamniotic twin pregnancy * IUGR * Preeclampsia or other PIH * TTTS * Uncontrolled diabetes * Other maternal of fetal pathology responsible for preterm deliveries * Patient included in other therapeutic trials * Patient without legal freedom to consent * Homeless or no fixed address
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate the profit of 10 days in the pessary group compared to control. | at least 10 days | Demonstrate the profit of 10 days in the pessary group compared to control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate and compare the frequency of the childbirth < 34 SA | before 34 weeks | — |
| Deliveries (<34WG) | 34 weeks | Deliveries (\<34WG) |
| Evaluate the rate of side effects of pessaries | during the pessaries | Evaluate the rate of side effects of pessaries |
| Neonatal outcome | before 28 weeks | Neonatal outcome |
Countries
France
Outcome results
None listed