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

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

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

Study Overview

• Status: Completed
• Conditions: Twin Pregnancy With Antenatal Problem
• Intervention / Treatment: Drug: Progesterone

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 400 mg progesterone group; Taking 400 mg vaginal progesterone	Drug: Progesterone; Taking prontogest vaginally
Active Comparator: 200 mg progesterone group; Taking 200 mg vaginal progesterone	Drug: Progesterone; Taking prontogest vaginally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm labor	Number of participants which had preterm labor	Before 37 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical length changes	Cervical length changes in centimeters	Between 14 weeks and 22 weeks gestation
Neonatal ICU admission	Number of neonates required neonatal ICU admission	The first 28 days after delivery
Neonatal mechanical ventilation	Number of neonates required mechanical ventilation	The first 28 days after delivery
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: January 31, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Progesterone; Preterm labor; Twin pregnancy
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: MS 483/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No