Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies

Phase 4

Completed

• Conditions: Twin Pregnancy With Antenatal Problem
• Interventions: Drug: Progesterone

• Registration Number: NCT04748562
• Lead Sponsor: Ain Shams University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-08-01
• Study Completion: 2020-12-01
• Study First Submitted: 2021-01-31
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-05
• Last Update Submitted: 2021-02-05
• Study First Posted: 2021-02-10
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Polyhydramnios
• Anemia
• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
400 mg progesterone group	Progesterone	Taking 400 mg vaginal progesterone
200 mg progesterone group	Progesterone	Taking 200 mg vaginal progesterone

Primary Outcome Measures

Name	Time	Method
Preterm labor	Before 37 weeks gestation	Number of participants which had preterm labor

Secondary Outcome Measures

Name	Time	Method
Cervical length changes	Between 14 weeks and 22 weeks gestation	Cervical length changes in centimeters
Neonatal ICU admission	The first 28 days after delivery	Number of neonates required neonatal ICU admission
Neonatal mechanical ventilation	The first 28 days after delivery	Number of neonates required mechanical ventilation
Progesterone side effects	During one year which is the period from the start of the study till its end	The number of patients experiencing progesterone side effects

Trial Locations

Locations (1)

Ain Shams University Maternity hospital; 🇪🇬 Cairo, Egypt