NCT03781674

Brief Summary

The objective of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

3 years

First QC Date

December 18, 2018

Last Update Submit

February 14, 2019

Conditions

Twin; Pregnancy, Affecting Fetus or Newborn

Keywords

Preterm birthTwin gestationVaginal progesterone

Outcome Measures

Primary Outcomes (1)

  • Preterm labor before 34 weeks gestations

    Number of patients delivered before 34 weeks gestations

    Up to 34 weeks gestational age

Secondary Outcomes (1)

  • Neonatal respiratory distress syndrome

    At birth

Other Outcomes (1)

  • Early neonatal death

    One month after birth

Study Arms (3)

progesterone 400mg

ACTIVE COMPARATOR

Women received vaginal progesterone suppositories in a dose of 400 mg(4 tablets) daily beginning at 18-22 weeks gestational age

Drug: progesterone 400mg

progesterone 200mg plus placebo to progesterone 200 mg

ACTIVE COMPARATOR

Women received vaginal progesterone suppositories in a dose of 200 mg(2 tablets) daily beginning at 18-22 weeks gestational age plus 2tablets placebo to vaginal progesterone

Drug: progesterone 200mgDrug: placebo to progesterone 200mg

placebo to progesterone 400 mg

PLACEBO COMPARATOR

Women received 4 tablets placebo to vaginal progesterone suppositories

Drug: placebo to progesterone 200mgDrug: placebo to progesterone 400mg

Interventions

progesterone 400mgDRUG

Women received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 18-22 weeks gestational age

Also known as: Active Comparator
progesterone 400mg
progesterone 200mgDRUG

Women received vaginal progesterone suppositories in a dose of 200 mg daily beginning at 18-22 weeks gestational age

Also known as: Active Comparator
progesterone 200mg plus placebo to progesterone 200 mg
placebo to progesterone 200mgDRUG

Women received placebo to vaginal progesterone 200 mg suppositories in a dose of (2 tablets) daily beginning at 18-22 weeks gestational age

Also known as: Placebo comparator
placebo to progesterone 400 mgprogesterone 200mg plus placebo to progesterone 200 mg
placebo to progesterone 400mgDRUG

Women received placebo to vaginal progesterone 400 mg suppositories in a dose of (4 tablets) daily beginning at 18-22 weeks gestational age

Also known as: placebo comparator
placebo to progesterone 400 mg

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen pregnant in dichorionic twins.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women pregnant in dichorionic twins.
  • Transvaginal sonographic cervical length is \<25 mm at 18-22 weeks gestational age.
  • No symptoms, signs or other risk factors for preterm labor.

You may not qualify if:

  • Known allergy or contraindication (relative or absolute) to progesterone therapy.
  • Monochorionic twins.
  • Known major fetal structural or chromosomal abnormality.
  • Intrauterine death of one fetus or death of both fetuses.
  • Fetal reduction in the current pregnancy.
  • Cervical cerclage in the current pregnancy.
  • Medical conditions that may lead to preterm delivery.
  • Rupture of membranes.
  • Vaginal bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • hany f sallam, md

    Aswan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hany f sallam, md

CONTACT

01022336052hany.farouk@aswu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
a double-blind randomized controlled trial
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: a double-blind randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 18, 2018

First Posted

December 20, 2018

Study Start

January 1, 2019

Primary Completion

December 31, 2021

Study Completion

March 1, 2022

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

EG(1)