Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-01-01 @ 6:38 AM
Study NCT ID:
NCT03353012
Status:
COMPLETED
Last Update Posted:
2019-07-26
First Post:
2017-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant
Sponsor:
Chulalongkorn University
Organization:
Study Overview
Official Title:
Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: