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CompletedNCT06100783Updated Oct 25, 2023

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

An interventional study of Depot-medroxy Progesterone Acetate Injectable Contraceptives in Complications of DMPA Injectable Contraceptives, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-25.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Jan 2021, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Complications of DMPA Injectable Contraceptives
03

In context

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Women using DMPA after 6 weeks postpartum

    Device: Depot-medroxy Progesterone Acetate Injectable Contraceptives

  • Experimental
    Women using DMPA after 1 week postpartum

    Device: Depot-medroxy Progesterone Acetate Injectable Contraceptives

Interventions

  • DeviceDepot-medroxy Progesterone Acetate Injectable Contraceptives

    Depot-medroxy progesterone acetate injectable contraceptives

06

What researchers measure

Primary outcomes

  1. Pattern of vaginal bleeding postpartum

    Number of bleeding days- number of pads per day

    Time frame: 2021 to 2023

Secondary outcomes

  1. Duration and frequency of breast milk

    score of frequency of breast feeding

    Time frame: 2021 to 2023

07

Study locations

1 site
  • Boshra Hussien Ahmed
    Asyut, 71111, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06100783
Lead sponsor
Assiut University
Responsible party
Boshra Hussien (Specialist of Reproductive Health, Assiut University) — Principal investigator
First posted
Oct 25, 2023
Start date
Jan 1, 2021
Primary completion
Aug 1, 2022
Completion
Oct 1, 2023
Last update
Oct 25, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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