Depot-medroxy Progesterone Acetate Injectable Contraceptives in Lactating Women 1st Week Versus 6 Week Postpartum Initiation

October 20, 2023 updated by: Boshra Hussien, Assiut University

This study aims to identify the effect of using Depot-medroxy progesterone acetate injectable contraceptives on lactating women mother and infant in 1st week versus 6th week postpartum initiation.

This study is open labeled -randomized clinical trial was used. It was conducted at woman's health hospital, Assuit University. This study applied on 120 lactating women, who divided into two equal group I (who used DMPA injectable in the 1st week postpartum) and group II (who used DMPA injectable in the 6th week postpartum). Each group included 60 lactating women). Follow up was carried out after 3 months from the first dose to determine the changes in the studied women's menstrual period, weight, breast feedings…etc.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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

  • Egypt
      • Assiut, Egypt, 71111
        • Boshra Hussien Ahmed

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Desire contraception for at least one year Apparently healthy participant Age 20- 40 years old Term delivery Birth weight >2.5 kg multipara Intend to breastfeed at time of hospital discharge Those delivered normally or by caesarean section Ready to follow and need immediate contraception

Exclusion Criteria:

Maternal health problems (DM, HTN, cardiac disease, anaemia, or any other obvious problem) Any maternal complications during labour Preterm delivery IUGR

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Women using DMPA after 6 weeks postpartum
Device: Depot-medroxy Progesterone Acetate Injectable Contraceptives
Depot-medroxy progesterone acetate injectable contraceptives
Experimental: Women using DMPA after 1 week postpartum
Device: Depot-medroxy Progesterone Acetate Injectable Contraceptives
Depot-medroxy progesterone acetate injectable contraceptives

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of vaginal bleeding postpartum
Time Frame: 2021 to 2023
Number of bleeding days- number of pads per day
2021 to 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration and frequency of breast milk
Time Frame: 2021 to 2023
score of frequency of breast feeding
2021 to 2023

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 (Actual)

January 1, 2021

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

October 15, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • boshahussien2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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