Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant

Breastfeeding Clinical Trial

Official title:

Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353012
• Other study ID #: Sitanan Lertsiripanich
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: October 2017
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding
• Post Partum

Intervention

Drug:
• Etonogestrel Drug Implant
Etonogestrel 68 mg (single rod) is implanted at inner arm of participant.
• Levonorgestrel Drug Implant
Levonorgestrel 75 mg (2 rods) are implanted at inner arm of participant.

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Pathum Wan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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