17-Alpha-Hydroxyprogesterone Caproate in Pregnant Women With Placenta Previa

February 14, 2019 updated by: hany farouk, Aswan University Hospital

Intramuscular 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Symptomatic Pregnant Women With Placenta Previa: A Randomized Controlled Study

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

Study Overview

Status

Unknown

Conditions

Detailed Description

Most authors report an increased risk of bleeding with advancing gestation among women with placenta previa.

The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) both recommend the use of 17-OHPC to prevent recurrent spontaneous preterm birth.

Preterm deliveries account for 75% of perinatal mortality and surviving preterm infants are at risk for neurological, respiratory, and gastrointestinal complications. So, it is therefore very important to try to prolong the pregnancy without increasing the risk of emergent delivery in cases with placenta previa. The authors hypothesized that a pharmacological strategy like 17-alpha-Hydroxyprogesterone caproate may improve pregnancy outcomes and may also allow obstetricians to tailor their approach to save delayed scheduled cesarean section women with a placenta previa.

The aim of this study to evaluate the role of17-alpha-Hydroxyprogesterone caproate in the prevention of preterm cesarean delivery (CD) in cases with symptomatic placenta previa with avoids of an emergent CD which affects the maternal outcome and prevents prematurity which affects the prenatal outcome.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aswan, Egypt, 81528
        • Recruiting
        • Aswan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 17-OHPC
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
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
Other Names:
  • Active Comparator
  • cidolut depot
PLACEBO_COMPARATOR: placebo to 17-OHPC
patients received weekly placebo to 17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
patients received weekly placebo to17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
Other Names:
  • Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the duration of prolongation of pregnancy from the time of enrollment to the time of delivery
Time Frame: 6 weeks
measure the duration of prolongation of pregnancy in days measured from the time of enrollment to the time of delivery
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
apgar score
Time Frame: 5 minutes postpartum
measure apgar score from 0 to 10
5 minutes postpartum
the number of patients with postpartum hemorrhage
Time Frame: 24 hours post operative
calculation the number of patients with postpartum hemorrhage
24 hours post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

March 1, 2022

Study Registration Dates

First Submitted

December 15, 2018

First Submitted That Met QC Criteria

December 15, 2018

First Posted (ACTUAL)

December 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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