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

Twin Pregnancy With Antenatal Problem Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04748562
• Other study ID #: MS 483/2019
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Twin Pregnancy With Antenatal Problem

Intervention

Drug:
• Progesterone
Taking prontogest vaginally

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm labor	Number of participants which had preterm labor	Before 37 weeks gestation
Secondary	Cervical length changes	Cervical length changes in centimeters	Between 14 weeks and 22 weeks gestation
Secondary	Neonatal ICU admission	Number of neonates required neonatal ICU admission	The first 28 days after delivery
Secondary	Neonatal mechanical ventilation	Number of neonates required mechanical ventilation	The first 28 days after delivery
Secondary	Progesterone side effects	The number of patients experiencing progesterone side effects	During one year which is the period from the start of the study till its end