Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant

Chulalongkorn University

Status and phase: Completed; Phase 4

Conditions: Breastfeeding; Post Partum

Treatments: Drug: Levonorgestrel Drug Implant; Drug: Etonogestrel Drug Implant

Study type: Interventional

Funder types: Other

Identifiers

NCT03353012

Sitanan Lertsiripanich

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Levonorgestrel immediate post-partum

Experimental group

Description:

Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 48-72 hr after child delivery

Treatment:

Drug: Levonorgestrel Drug Implant

Etonogestrel immediate post-partum

Experimental group

Description:

Breast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 48-72 hr after child delivery

Treatment:

Drug: Etonogestrel Drug Implant

Levonorgestrel delayed post-partum

Active Comparator group

Description:

Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 5-7 weeks after child delivery

Treatment:

Drug: Levonorgestrel Drug Implant

Etonogestrel delayed post-partum

Active Comparator group

Description:

Breast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 5-7 weeks after child delivery

Treatment:

Drug: Etonogestrel Drug Implant