Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies: a Randomised Controlled Trial

Ain Shams University1 site in 1 country100 target enrollmentJanuary 1, 2020

ConditionsTwin Pregnancy With Antenatal Problem

InterventionsProgesterone

DrugsProgesterone

Overview

Phase: Phase 4
Intervention: Progesterone
Conditions: Twin Pregnancy With Antenatal Problem
Sponsor: Ain Shams University
Enrollment: 100
Locations: 1
Primary Endpoint: Preterm labor
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

It is already known that the risk of preterm labor in twin pregnancy before 37 week is 8-9 fold higher compared to singletons, and progesterone supplementation can decrease the incidence of preterm labor in singleton pregnancy.

There were studies that used 200mg vaginal progesterone with no effect on the result So this study aims To examine the effect of prophylactic vaginal progesterone 400mg v.s 200mg for prevention of preterm birth in twin pregnancies

Registry

clinicaltrials.gov

Start Date

January 1, 2020

End Date

December 1, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Ain Shams University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Primigravidae
•Twin pregnancies at gestational age 14 week.
•Cervical length more than 2 cm (because if 2cm or less they will undergo cervical cerclage.)

Exclusion Criteria

•Polyhydramnios
•Twins with congenital malformation
•Twin to twin transfusion
•Medical diseases as diabetes mellitus, hypertension and systemic lupus erythematosis
•Previous cervical surgery
•High order pregnancy (triples or more)

Arms & Interventions

400 mg progesterone group

Taking 400 mg vaginal progesterone

Intervention: Progesterone

200 mg progesterone group

Taking 200 mg vaginal progesterone

Intervention: Progesterone

Outcomes

Primary Outcomes

Preterm labor

Time Frame: Before 37 weeks gestation

Number of participants which had preterm labor

Secondary Outcomes

Cervical length changes(Between 14 weeks and 22 weeks gestation)
Neonatal ICU admission(The first 28 days after delivery)
Neonatal mechanical ventilation(The first 28 days after delivery)
Progesterone side effects(During one year which is the period from the start of the study till its end)