- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06936436
the Effect of Implanon on Menstrual Patterns
April 18, 2025 updated by: Kholoud Khalid Kamal, Assiut University
the Effect of Implanon on Menstrual Patterns According to Timing of Insertion After Delivery
This study aims to evaluate whether the timing of postpartum Implanon insertion (immediately postpartum, early postpartum, or late postpartum) affects menstrual patterns
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
- Etonogestrel implants (Implanon) are widely used for postpartum contraception. However, the timing of insertion may influence menstrual patterns, including irregular bleeding, amenorrhea, and prolonged bleeding episodes. Despite the increasing use of immediate postpartum contraception, there is limited research on how the timing of Implanon insertion affects menstrual cycle regulation.
- Furthermore, lactation and hormonal changes postpartum may modify the bleeding patterns in women using Implanon, with breastfeeding women experiencing a higher likelihood of amenorrhea due to prolactin-induced suppression of ovulation.
- This study aims to fill these gaps by systematically comparing menstrual outcomes based on timing of Implanon insertion postpartum
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: kholoud khalid KAMAL
- Phone Number: 01013224377
- Email: kholoud.khalid494@GMAIL.COM
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Women will be grouped into:
- Immediate postpartum (Insertion within 48 hours of delivery).
- Early postpartum (Insertion between 4-6 weeks postpartum).
- Late postpartum (Insertion after 6 weeks postpartum
Description
Inclusion Criteria:
- Postpartum women opting for Implanon as contraception.
- No contraindications to hormonal contraception.
Exclusion Criteria:
- . Women with known bleeding disorders.
- Use of other hormonal contraceptives during the study period.
- Postpartum complications such as severe infections or retained products of conception
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Effect of Implanon on Menstrual Patterns According to Timing of Insertion After Delivery
Time Frame: baseline
|
To compare the effect of Implanon insertion at different postpartum intervals (immediate, early, late) on menstrual cycle patterns
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: AHMED MOHAMED ABBAS, PROF.DR, Assiut University
- Study Chair: MOHAMED SAYED ABDELLAH, PROF.DR, Assiut University
- Study Chair: ALAA AHMED MAKHLOUF, DR, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mazza D, Harrison C, Taft A, Brijnath B, Britt H, Hobbs M, Stewart K, Hussainy S. Current contraceptive management in Australian general practice: an analysis of BEACH data. Med J Aust. 2012 Jul 16;197(2):110-4. doi: 10.5694/mja11.11599.
- Richters J, Grulich AE, de Visser RO, Smith AM, Rissel CE. Sex in Australia: contraceptive practices among a representative sample of women. Aust N Z J Public Health. 2003;27(2):210-6. doi: 10.1111/j.1467-842x.2003.tb00810.x.
- . Product information: Implanon NXT, Schering-Plough Pty Ltd, 12 November 2010
- Product information: Implanon® Implant, Organon (Australia) Pty Ltd, 19 March 2008.
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 (Estimated)
May 1, 2025
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
April 13, 2025
First Submitted That Met QC Criteria
April 13, 2025
First Posted (Actual)
April 20, 2025
Study Record Updates
Last Update Posted (Actual)
April 23, 2025
Last Update Submitted That Met QC Criteria
April 18, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- effect of implanon
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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