Protocols for Prevention of PPH During CS in High Risk Group

October 19, 2021 updated by: Randa Wanees Ahmed, Assiut University

Different Protocols for Prevention of Atonic Postpartum Hemorrhage During Cesarean Delivery in High Risk Group

PPH is one of the most leading causes of maternal mortality,. It means loss of 500 ml blood after vaginal delivery and 1000 ml blood after cesarean delivery. Although it's preventable it represents about 27%of maternal deaths. Atony is the main cause of PPH. 70%of PPH corresponds to uterine atony. Uterotonics like oxytocin, misoprostol, ergometrine, carbetocin and combinations of these drugs can be used but until now there is no agreement on medication that can be the most effective.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

448

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

19 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Prevention of atonic PPH during CD in high risk group

Description

Inclusion Criteria:

  • 1. Pregnant full term>37 w 2. Maternal age 19- 40 3.physical state 1&2 4.patient willing to enter the study

Exclusion Criteria:

  • 1.who refuse to participate in study 2.immunocomprmized and patients who had contraindicated from any of drugs used 3.patients with hypersensitivity to any drug

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

  • Observational Models: Case-Crossover
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women who receive oxytocin
Drug: Syntocinon, papal, misotac
Using different drugs to prevent atonic PPH during CD in high risk group
Pregnant Women who receive carbetocin
Drug: Syntocinon, papal, misotac
Using different drugs to prevent atonic PPH during CD in high risk group
Pregnant women who receive misoprostol
Drug: Syntocinon, papal, misotac
Using different drugs to prevent atonic PPH during CD in high risk group
Pregnant women who receive ergometrine
Drug: Syntocinon, papal, misotac
Using different drugs to prevent atonic PPH during CD in high risk group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of blood loss
Time Frame: 1 year
Decrease amount of blood loss
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Finding the drug most effective with least adverse effects
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Anticipated)

October 30, 2021

Primary Completion (Anticipated)

October 30, 2022

Study Completion (Anticipated)

October 30, 2022

Study Registration Dates

First Submitted

October 19, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Atonic PPH in high risk group

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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