Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant

Study Overview
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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.

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

Official Title
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Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant

Conditions
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Breastfeeding, Post Partum

Intervention / Treatment
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* Drug: Etonogestrel Drug Implant
* Drug: Levonorgestrel Drug Implant


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levonorgestrel immediate post-partum<br>Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 48-72 hr after child delivery | Drug: Levonorgestrel Drug Implant<br>* Levonorgestrel 75 mg (2 rods) are implanted at inner arm of participant.<br>* Other names: Jadelle;|
| Experimental: Etonogestrel immediate post-partum<br>Breast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 48-72 hr after child delivery | Drug: Etonogestrel Drug Implant<br>* Etonogestrel 68 mg (single rod) is implanted at inner arm of participant.<br>* Other names: Implanon;|
| Active Comparator: Levonorgestrel delayed post-partum<br>Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 5-7 weeks after child delivery | Drug: Levonorgestrel Drug Implant<br>* Levonorgestrel 75 mg (2 rods) are implanted at inner arm of participant.<br>* Other names: Jadelle;|
| Active Comparator: Etonogestrel delayed post-partum<br>Breast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 5-7 weeks after child delivery | Drug: Etonogestrel Drug Implant<br>* Etonogestrel 68 mg (single rod) is implanted at inner arm of participant.<br>* Other names: Implanon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | immediately after contraceptive implant use until 12 weeks after use | 
| Removal rate of contraceptive implants users | To compare tolerance between Immediate and delayed breastfeeding postpartum contraceptive users, by collecting and calculating removal rate of users. | immediately after contraceptive implant use until 12 weeks after use | 
| Satisfactory of contraceptive implant users | To compare acceptability between Immediate and delayed breastfeeding postpartum contraceptive users, using questionnaire rating satisfactory scale by score from 1 to 5 | immediately after contraceptive implant use until 12 weeks after use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding status | 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. | immediately after contraceptive implant use until 12 weeks after use | 
| Child weight | To compare child growth by measuring weight, between Immediate and delayed breastfeeding postpartum contraceptive users. | immediately after contraceptive implant use until 12 weeks after use | 
| Child height | To compare child growth by measuring height, between Immediate and delayed breastfeeding postpartum contraceptive users. | immediately after contraceptive implant use until 12 weeks after use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levonorgestrel, Immediate postpartum implant, postpartum implant, implant contraception, Etonogestrel