Immediate Versus Delayed Postpartum Insertion of Etonogestrel Implants (Implanon-NXT) in Terms of Side Effect and Patients' Satisfaction: A Prospective Observational Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
研究概览
简要总结
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.
详细描述
2.4.1- Type of study: A prospective observational cohort study. 2.4.2- Study Setting: Assiut General Hospital . 2.4.3- Study subjects:
-
Inclusion Criteria:
-
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.
-
Exclusion Criteria:
-
Known or suspected current pregnancy.
-
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
-
Known hypersensitivity to etonogestrel or any component of the implant device.
-
Inability or unwillingness to provide written informed consent.
C. Sample Size Calculation:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •1. Known or suspected current pregnancy.
- •Postpartum hemorrhage requires uterotonic therapy at the time of planned insertion.
- •3. Chorioamnionitis, puerperal sepsis, or any active pelvic or systemic infection at the time of insertion.
- •4. Not eligible for Implanon-NXT insertion according to WHO criteria
- •Known hypersensitivity to etonogestrel or any component of the implant device.
- •6. Inability or unwillingness to provide written informed consent. (2)
研究者
Aya Mostafa Lisy Lisy
principal investigator
Assiut University