Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-08-01

Brief Summary

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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.

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Detailed Description

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* 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

Conditions

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Breastfeeding Post Partum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levonorgestrel immediate post-partum

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

Group Type EXPERIMENTAL

Levonorgestrel Drug Implant

Intervention Type DRUG

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

Etonogestrel immediate post-partum

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

Group Type EXPERIMENTAL

Etonogestrel Drug Implant

Intervention Type DRUG

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

Levonorgestrel delayed post-partum

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

Group Type ACTIVE_COMPARATOR

Levonorgestrel Drug Implant

Intervention Type DRUG

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

Etonogestrel delayed post-partum

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

Group Type ACTIVE_COMPARATOR

Etonogestrel Drug Implant

Intervention Type DRUG

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

Interventions

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Etonogestrel Drug Implant

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

Intervention Type DRUG

Levonorgestrel Drug Implant

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

Intervention Type DRUG

Other Intervention Names

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Implanon Jadelle

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes