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

NCT04748562 | Completed Phase 4

• 1 other identifier: MS 483/2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Twin Pregnancy With Antenatal Problem

Keywords

Progesterone; Twin pregnancy; Preterm labor

Outcome Measures

Primary Outcomes (1)

• Preterm labor

  Number of participants which had preterm labor

  Before 37 weeks gestation

Secondary Outcomes (4)

• 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

Study Arms (2)

400 mg progesterone group

ACTIVE COMPARATOR

Taking 400 mg vaginal progesterone

Drug: Progesterone

200 mg progesterone group

ACTIVE COMPARATOR

Taking 200 mg vaginal progesterone

Drug: Progesterone

Interventions

Progesterone DRUG

Taking prontogest vaginally

200 mg progesterone group; 400 mg progesterone group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Maternity hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 10, 2021
• Study Start: January 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

EG (1)