NCT03779451

Brief Summary

Purpose to evaluate the effects of Vaginal Progesterone versus 17-Alpha-Hydroxyprogesterone Caproate for prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women with Placenta Previa

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
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
13 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
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

3 years

First QC Date

December 15, 2018

Last Update Submit

February 14, 2019

Conditions

Placenta Previa

Keywords

cesarean sectionplacenta previaantepartum hemorrhagevaginal progesterone17-Alpha-Hydroxyprogesterone Caproate

Outcome Measures

Primary Outcomes (1)

  • number of patient delivered before 37 weeks

    calculation the number of patients delivered before 37 weeks

    2 month

Secondary Outcomes (3)

  • number of episodes of antepartum hemorrhage

    2 month

  • Hospital admission for significant antepartum hemorrhage

    2 month

  • Neonatal Birth weight

    one hours post operative

Study Arms (3)

17-OHPC

ACTIVE COMPARATOR

patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 week and up to 37-weeks' gestation or delivery

Drug: 17-OHPC

vaginal progesterone

ACTIVE COMPARATOR

vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily at bedtime starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery

Drug: vaginal progesterone

control group

NO INTERVENTION

Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone.

Interventions

17-OHPCDRUG

received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 week and up to 37-weeks' gestation or delivery.

Also known as: Active Comparator, cidolut depot
17-OHPC
vaginal progesteroneDRUG

vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery

Also known as: Active Comparator, Cyclogest
vaginal progesterone

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women with placenta previa
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Gestational age 26-28 weeks of gestation.
  • Definite and reliable diagnosis of placenta previa (defined as the presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan

You may not qualify if:

  • Multiple pregnancies.
  • Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabour rupture of the membranes (PPROM).
  • Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent -intervention and delivery.
  • Women who have been maintained on progestin therapy since early pregnancy for whatever reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Previa

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta 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
NONE
Masking Details
An open-label randomized controlled study
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 15, 2018

First Posted

December 19, 2018

Study Start

January 1, 2019

Primary Completion

December 31, 2021

Study Completion

April 1, 2022

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

EG(1)