Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant

Chulalongkorn University60 enrolled

Overview

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.

* 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breastfeeding Post Partum

Interventions

Etonogestrel Drug ImplantDRUG

Etonogestrel 68 mg (single rod) is implanted at inner arm of participant.

Levonorgestrel Drug ImplantDRUG

Levonorgestrel 75 mg (2 rods) are implanted at inner arm of participant.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, Thailand

Outcomes

Primary Outcomes

Number of participants with treatment-related adverse events

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.