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

NCT ID: NCT06100783

Last Updated: 2023-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Complications of DMPA Injectable Contraceptives

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Women using DMPA after 6 weeks postpartum

Group Type EXPERIMENTAL

Depot-medroxy Progesterone Acetate Injectable Contraceptives

Intervention Type DEVICE

Depot-medroxy progesterone acetate injectable contraceptives

Women using DMPA after 1 week postpartum

Group Type EXPERIMENTAL

Depot-medroxy Progesterone Acetate Injectable Contraceptives

Intervention Type DEVICE

Depot-medroxy progesterone acetate injectable contraceptives

Interventions

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Depot-medroxy Progesterone Acetate Injectable Contraceptives

Depot-medroxy progesterone acetate injectable contraceptives

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Boshra Hussien

Specialist of Reproductive Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Boshra Hussien Ahmed

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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boshahussien2021

Identifier Type: -

Identifier Source: org_study_id

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