Immediate vs Delayed Postpartum Implanon-NXT

NCT07626502 | Not Yet Recruiting

• 1 other identifier: Implanon-PP-Study
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective observational cohort study aims to compare immediate postpartum insertion (within 72 hours after delivery) versus delayed insertion (4-6 weeks postpartum) of the etonogestrel subdermal implant (Implanon-NXT®️) regarding side effects, bleeding patterns, implant-related complications, breastfeeding outcomes, continuation rates, and patient satisfaction. The study will be conducted at Assiut General Hospital and will include 100 postpartum women aged 18-45 years who delivered at term and chose Implanon-NXT®️ as their contraceptive method. Participants will be divided into two groups according to timing of insertion: immediate postpartum and delayed postpartum insertion. Baseline assessment will include detailed medical and obstetric history, clinical examination, complete blood count, coagulation profile, liver function tests, and breastfeeding evaluation. Implant insertion will be performed according to standard IMPLANON-NXT®️ guidelines under aseptic conditions by trained clinicians. Participants will be followed at 6 weeks, 3 months, 6 months, and 12 months after insertion. Follow-up evaluation will include assessment of bleeding patterns using WHO Belsey definitions, implant-site complications, breastfeeding status, side effects, continuation rates, unintended pregnancy, and patient satisfaction using a validated Likert-scale questionnaire. Laboratory investigations and transvaginal Doppler ultrasound of the uterine artery will also be performed during follow-up visits. Data will be analyzed using IBM SPSS version 29. Statistical significance will be considered at p \< 0.05. The study aims to provide evidence regarding the optimal timing of postpartum Implanon-NXT®️ insertion to improve contraceptive outcomes and patient satisfaction.

Conditions

Delayed and Secondary Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (2)

• patient satisfaction with postpartum Nexplanon insertion

  patient satisfaction assessed using a structured satisfaction questionnaire

  12 months after implant insertion

• Bleeding pattern changes after Nexplanon insertion

  Bleeding patterns assessed using participant menstrual diaries and classified as amenorrhea , infrequent bleeding according to WHO bleeding pattern definitions

  12 months after implant insertion

Secondary Outcomes (3)

• Incidence of implant-related complications

  12 months after impalnt insertion

• Breastfeeding continuation rate

  12 months postpartum

• Change in hemoglobin level

  Basline, 3 months , and 6 months after insertion

Interventions

Etonogestrel subdermal implant (Implanon-NXT®) DEVICE

The intervention consists of insertion of a single-rod etonogestrel subdermal contraceptive implant (Implanon-NXT®, 68 mg) in eligible postpartum women. The implant will be inserted under strict aseptic conditions by trained clinicians following standard manufacturer guidelines. Participants will be allocated into two cohorts according to timing of insertion: (1) immediate postpartum insertion within 72 hours after delivery (vaginal or cesarean section), and (2) delayed insertion at 4-6 weeks postpartum during the routine postnatal visit. Prior to insertion, all women will undergo clinical assessment, confirmation of eligibility, counseling regarding risks, benefits, and expected changes in bleeding patterns, and written informed consent. The device is placed subdermally in the inner aspect of the upper arm using a preloaded applicator. Participants will be followed for 12 months to assess side effects, bleeding patterns, complications, breastfeeding outcomes, and satisfaction.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Postpartum women aged 18-45 years who delivered at term and desire long-acting reversible contraception.

You may qualify if:

• Women who delivered vaginally or by caesarean section at term (≥37 weeks of gestation).
• Age between 18 and 45 years.
• Desire to use the etonogestrel subdermal implant (Implanon-NXT®) as a method of contraception.
• Willing to provide written informed consent prior to enrollment.

You may not qualify if:

• \. Known or suspected current pregnancy. 2. Postpartum hemorrhage requires uterotonic therapy at the time of planned insertion.
• \. Chorioamnionitis, puerperal sepsis, or any active pelvic or systemic infection at the time of insertion.
• \. Not eligible for Implanon-NXT insertion according to WHO criteria 5. Known hypersensitivity to etonogestrel or any component of the implant device.
• \. Inability or unwillingness to provide written informed consent. (2)

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share