NCT03353012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

July 26, 2019

Status Verified

October 1, 2017

Enrollment Period

4 months

First QC Date

October 15, 2017

Last Update Submit

July 25, 2019

Conditions

BreastfeedingPost Partum

Keywords

Immediate postpartum implantpostpartum implantimplant contraceptionEtonogestrelLevonorgestrel

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Breastfeeding status

    immediately after contraceptive implant use until 12 weeks after use

  • Child weight

    immediately after contraceptive implant use until 12 weeks after use

  • Child height

    immediately after contraceptive implant use until 12 weeks after use

Study Arms (4)

Levonorgestrel immediate post-partum

EXPERIMENTAL

Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 48-72 hr after child delivery

Drug: Levonorgestrel Drug Implant

Etonogestrel immediate post-partum

EXPERIMENTAL

Breast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 48-72 hr after child delivery

Drug: Etonogestrel Drug Implant

Levonorgestrel delayed post-partum

ACTIVE COMPARATOR

Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 5-7 weeks after child delivery

Drug: Levonorgestrel Drug Implant

Etonogestrel delayed post-partum

ACTIVE COMPARATOR

Breast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 5-7 weeks after child delivery

Drug: Etonogestrel Drug Implant

Interventions

Etonogestrel Drug ImplantDRUG

Etonogestrel 68 mg (single rod) is implanted at inner arm of participant.

Also known as: Implanon
Etonogestrel delayed post-partumEtonogestrel immediate post-partum
Levonorgestrel Drug ImplantDRUG

Levonorgestrel 75 mg (2 rods) are implanted at inner arm of participant.

Also known as: Jadelle
Levonorgestrel delayed post-partumLevonorgestrel immediate post-partum

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Breast-feeding post-partum woman aged 18-45 years who wish to use contraceptive implant

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 36302159DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

etonogestrel

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Unnop Jaisamrarn, M.D.

    Chulalongkorn University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2017

First Posted

November 24, 2017

Study Start

January 1, 2018

Primary Completion

May 1, 2018

Study Completion

August 1, 2018

Last Updated

July 26, 2019

Record last verified: 2017-10

Locations

TH(1)