Complications of DMPA Injectable ContraceptivesNCT06100783
Depot-medroxy Progesterone Acetate Injectable Contraceptives in Lactating Women 1st Week Versus 6 Week Postpartum Initiation
A study testing Depot-medroxy Progesterone Acetate Injectable Contraceptives in people with Complications of DMPA Injectable Contraceptives, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complications of DMPA Injectable Contraceptives
- What is being tested?
- Depot-medroxy Progesterone Acetate Injectable Contraceptives
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Maternal health problems (DM, HTN, cardiac disease, anaemia, or any other obvious problem) Any maternal complications during labour Preterm delivery IUGR
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Depot-medroxy Progesterone Acetate Injectable Contraceptives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depot-medroxy Progesterone Acetate Injectable ContraceptivesDevice
Depot-medroxy progesterone acetate injectable contraceptives
| Study group | Role | What they receive |
|---|---|---|
| Women using DMPA after 6 weeks postpartum | Experimental | Not described Receives: Device: Depot-medroxy Progesterone Acetate Injectable Contraceptives |
| Women using DMPA after 1 week postpartum | Experimental | Not described Receives: Device: Depot-medroxy Progesterone Acetate Injectable Contraceptives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of vaginal bleeding postpartum
Number of bleeding days- number of pads per day
Measured: 2021 to 2023
Secondary outcomes (1)
Duration and frequency of breast milk
score of frequency of breast feeding
Measured: 2021 to 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Jan 2021
- Primary completion1 Aug 2022
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications of DMPA Injectable ContraceptivesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boshra Hussien, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100783
- Sponsor's protocol ID
- boshahussien2021
- Status last verified
- Oct 2023
- First submitted
- 15 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depot-medroxy Progesterone Acetate Injectable Contraceptives in Lactating Women 1st Week Versus 6 Week Postpartum Initiation
- ClinicalTrials.gov ID
- NCT06100783
- Acronym / sponsor ID
- boshahussien2021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women using DMPA after 6 weeks postpartum | Experimental | Device: Depot-medroxy Progesterone Acetate Injectable Contraceptives |
| Women using DMPA after 1 week postpartum | Experimental | Device: Depot-medroxy Progesterone Acetate Injectable Contraceptives |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Maternal health problems (DM, HTN, cardiac disease, anaemia, or any other obvious problem) Any maternal complications during labour Preterm delivery IUGR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depot-medroxy Progesterone Acetate Injectable ContraceptivesDepot-medroxy progesterone acetate injectable contraceptives | Device | Women using DMPA after 1 week postpartum, Women using DMPA after 6 weeks postpartum |
Primary outcome
Pattern of vaginal bleeding postpartum
Time frame: 2021 to 2023
Number of bleeding days- number of pads per day
1 secondary outcome
Duration and frequency of breast milk
Time frame: 2021 to 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Depot-medroxy Progesterone Acetate Injectable Contraceptives in people with Complications of DMPA Injectable Contraceptives, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of vaginal bleeding postpartum (time frame: 2021 to 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.