Clinical trial NCT03353012: Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant
Official title: Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breastfeeding
Post Partum
Keywords: Immediate postpartum implant
postpartum implant
implant contraception
Etonogestrel
Levonorgestrel
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: immediately after contraceptive implant use until 12 weeks after use
measure: Removal rate of contraceptive implants users
timeFrame: immediately after contraceptive implant use until 12 weeks after use
measure: Satisfactory of contraceptive implant users
timeFrame: immediately after contraceptive implant use until 12 weeks after use
Secondary outcomes:
measure: Breastfeeding status
timeFrame: immediately after contraceptive implant use until 12 weeks after use
measure: Child weight
timeFrame: immediately after contraceptive implant use until 12 weeks after use
measure: Child height
timeFrame: immediately after contraceptive implant use until 12 weeks after use
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok
Study officials:
affiliation: Chulalongkorn University
name: Unnop Jaisamrarn, M.D.
role: STUDY_CHAIR
References:
citation: Sothornwit J, Kaewrudee S, Lumbiganon P, Pattanittum P, Averbach SH. Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception. Cochrane Database Syst Rev. 2022 Oct 27;10(10):CD011913. doi: 10.1002/14651858.CD011913.pub3.