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

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04748562
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 11
• Patients Per Site Per Month: 9.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Twin Pregnancy With Antenatal Problem	Drug: Progesterone	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trialRandomized controlled trial
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies: a Randomised Controlled Trial
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Aug 1, 2020
• Actual Study Completion Date: Dec 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Preterm labor [Before 37 weeks gestation]

   Number of participants which had preterm labor

Secondary Outcome Measures

1. Cervical length changes [Between 14 weeks and 22 weeks gestation]

   Cervical length changes in centimeters

2. Neonatal ICU admission [The first 28 days after delivery]

   Number of neonates required neonatal ICU admission

3. Neonatal mechanical ventilation [The first 28 days after delivery]

   Number of neonates required mechanical ventilation

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Maternity hospital	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ain Shams University
• ClinicalTrials.gov Identifier: NCT04748562
• Other Study ID Numbers: MS 483/2019
• First Posted: Feb 10, 2021
• Last Update Posted: Feb 10, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ain Shams University: Progesterone; Twin pregnancy; Preterm labor
• Additional relevant MeSH terms: Obstetric Labor, Premature; Progesterone

Study Results

No Results Posted as of Feb 10, 2021