Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant

Phase 4

Completed

• Conditions: Breastfeeding; Post Partum
• Interventions: Drug: Levonorgestrel Drug Implant; Drug: Etonogestrel Drug Implant

• Registration Number: NCT03353012
• Lead Sponsor: Chulalongkorn University

Brief Summary

To study and compare acceptability and tolerance between breast-feeding post-partum woman, who receive contraceptive implant 48-72 hours after giving birth or at 5-7 weeks after giving birth, using either Levonorgestrel or Etonogestrel contraceptive implant.

Detailed Description

* To study and compare acceptability and tolerance between breast-feeding post-partum woman, who receive contraceptive implant 48-72 hours after giving birth or at 5-7 weeks after giving birth, using either Levonorgestrel or Etonogestrel contraceptive implant.

* Participants who wish to attend the study will be invited to choose between Levonorgestrel and Etonogestrel contraceptive implant, then they will be randomized into immediate postpartum or delay postpartum group. They will be follow-up at 6 and 12 weeks after receive contraceptive implant.

* Information about side effects, breastfeeding status, child growth, acceptability and tolerance will be noted using medical records and interviewing, gathering on paper case record forms.

* Sample size N = 60 (30 in each group (Immediate and delay postpartum group, 15 in each subgroup (Levonogestrel and Etonogestrel group)) This number of sample size is already counted with 10% data loss

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-15
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-24
• Study Start: 2018-01-01
• Primary Completion: 2018-05-01
• Study Completion: 2018-08-01
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Breast-feeding post-partum woman aged 18-45 years who wish to use contraceptive implant

Exclusion Criteria

• Pregnant
• Woman who has any medical conditions which is considered contraindicated to use contraceptive implant
• Woman with severe antepartum or peripartum complications
• Woman who is contraindicated to breastfeed.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levonorgestrel immediate post-partum	Levonorgestrel Drug Implant	Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 48-72 hr after child delivery
Etonogestrel immediate post-partum	Etonogestrel Drug Implant	Breast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 48-72 hr after child delivery
Levonorgestrel delayed post-partum	Levonorgestrel Drug Implant	Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 5-7 weeks after child delivery
Etonogestrel delayed post-partum	Etonogestrel Drug Implant	Breast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 5-7 weeks after child delivery

Primary Outcome Measures

Name	Time	Method
Removal rate of contraceptive implants users	immediately after contraceptive implant use until 12 weeks after use	To compare tolerance between Immediate and delayed breastfeeding postpartum contraceptive users, by collecting and calculating removal rate of users.
Satisfactory of contraceptive implant users	immediately after contraceptive implant use until 12 weeks after use	To compare acceptability between Immediate and delayed breastfeeding postpartum contraceptive users, using questionnaire rating satisfactory scale by score from 1 to 5
Number of participants with treatment-related adverse events	immediately after contraceptive implant use until 12 weeks after use	To compare treatment-related adverse events between Immediate and delayed breastfeeding postpartum contraceptive users, using case record form which specify bleeding days, spotting days, abdominal discomfort, headache, acne, alopecia, weight and blood pressure of users.

Secondary Outcome Measures

Name	Time	Method
Breastfeeding status	immediately after contraceptive implant use until 12 weeks after use	To compare breastfeeding status between Immediate and delayed breastfeeding postpartum contraceptive users by using questionnaire whether each participant is full-breastfeeding, partial-breastfeeding or non-breastfeeding and specify reasons if she's not full-breastfeeding.
Child weight	immediately after contraceptive implant use until 12 weeks after use	To compare child growth by measuring weight, between Immediate and delayed breastfeeding postpartum contraceptive users.
Child height	immediately after contraceptive implant use until 12 weeks after use	To compare child growth by measuring height, between Immediate and delayed breastfeeding postpartum contraceptive users.

Trial Locations

Locations (1)

King Chulalongkorn Memorial Hospital; 🇹🇭 Pathum Wan, Bangkok, Thailand