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Immediate vs Delayed Postpartum Implanon-NXT

NCT07626502 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2026-06-04

No results posted yet for this study

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

Interventions

DEVICE

Etonogestrel subdermal implant (Implanon-NXT®)

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-06-01
Completion
2027-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07626502 on ClinicalTrials.gov