NCT03779438

Brief Summary

Purpose to evaluate the effects of intramuscular 17-Alpha-Hydroxyprogesterone Caproate (17-OHPC) for prevention of Emergent Cesarean Delivery in symptomatic 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
300

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 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
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 15, 2018

Last Update Submit

February 14, 2019

Conditions

Placenta Previa

Keywords

cesarean sectionplacenta previaantepartum hemorrhage17-alpha-Hydroxyprogesterone caproate

Outcome Measures

Primary Outcomes (1)

  • the duration of prolongation of pregnancy from the time of enrollment to the time of delivery

    measure the duration of prolongation of pregnancy in days measured from the time of enrollment to the time of delivery

    6 weeks

Secondary Outcomes (2)

  • apgar score

    5 minutes postpartum

  • the number of patients with postpartum hemorrhage

    24 hours post operative

Study Arms (2)

17-OHPC

ACTIVE COMPARATOR

patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery

Drug: 17-OHPC

placebo to 17-OHPC

PLACEBO COMPARATOR

patients received weekly placebo to 17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery

Drug: placebo to 17-OHPC

Interventions

17-OHPCDRUG

patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery

Also known as: Active Comparator, cidolut depot
17-OHPC
placebo to 17-OHPCDRUG

patients received weekly placebo to17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery

Also known as: Placebo Comparator
placebo to 17-OHPC

Eligibility Criteria

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

You may qualify if:

  • Estimated gestational age: between 24 weeks and 37 week's gestation
  • Confirmed Placenta previa; either major or minor degrees.
  • Placenta previa with preterm uterine contractions or with a history of at least single attack of mild vaginal bleeding

You may not qualify if:

  • Severe attack of bleeding requiring an immediate intervention.
  • Fetal heart rates instability or non-reassuring tracing
  • Intrauterine fetal death or major fetal anomalies.
  • If associated with abruptio placentae
  • Patients with known bleeding disorders or on anticoagulant therapy
  • Patients with severe medical disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Officials

  • hany f sallam, md

    Aswan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hany f sallam

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 Clinical Trial
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A Double-Blind Randomized Clinical Trial
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

March 1, 2022

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

EG(1)