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

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06100783
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 33
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Complications of DMPA Injectable Contraceptives	Device: Depot-medroxy Progesterone Acetate Injectable Contraceptives	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Depot-medroxy Progesterone Acetate Injectable Contraceptives in Lactating Women 1st Week Versus 6 Week Postpartum Initiation
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Aug 1, 2022
• Actual Study Completion Date: Oct 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pattern of vaginal bleeding postpartum [2021 to 2023]

   Number of bleeding days- number of pads per day

Secondary Outcome Measures

1. Duration and frequency of breast milk [2021 to 2023]

   score of frequency of breast feeding

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boshra Hussien Ahmed	Assiut		Egypt	71111

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boshra Hussien, Specialist of Reproductive Health, Assiut University
• ClinicalTrials.gov Identifier: NCT06100783
• Other Study ID Numbers: boshahussien2021
• First Posted: Oct 25, 2023
• Last Update Posted: Oct 25, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Medroxyprogesterone Acetate; Contraceptive Agents; Medroxyprogesterone; Progesterone

Study Results

No Results Posted as of Oct 25, 2023