Breastfeeding, Post Partum
Conditions
Keywords
Immediate postpartum implant, postpartum implant, implant contraception, Etonogestrel, Levonorgestrel
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
Interventions
DRUGEtonogestrel Drug Implant
Etonogestrel 68 mg (single rod) is implanted at inner arm of participant.
Levonorgestrel 75 mg (2 rods) are implanted at inner arm of participant.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Thailand
Outcome results
None listed