Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant

July 25, 2019 updated by: Chulalongkorn University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Pathum Wan, Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levonorgestrel immediate post-partum
Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 48-72 hr after child delivery
Drug: Levonorgestrel Drug Implant
Levonorgestrel 75 mg (2 rods) are implanted at inner arm of participant.
Other Names:
  • Jadelle
Experimental: Etonogestrel immediate post-partum
Breast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 48-72 hr after child delivery
Drug: Etonogestrel Drug Implant
Etonogestrel 68 mg (single rod) is implanted at inner arm of participant.
Other Names:
  • Implanon
Active Comparator: Levonorgestrel delayed post-partum
Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 5-7 weeks after child delivery
Drug: Levonorgestrel Drug Implant
Levonorgestrel 75 mg (2 rods) are implanted at inner arm of participant.
Other Names:
  • Jadelle
Active Comparator: Etonogestrel delayed post-partum
Breast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 5-7 weeks after child delivery
Drug: Etonogestrel Drug Implant
Etonogestrel 68 mg (single rod) is implanted at inner arm of participant.
Other Names:
  • Implanon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events
Time Frame: 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.
immediately after contraceptive implant use until 12 weeks after use
Removal rate of contraceptive implants users
Time Frame: 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.
immediately after contraceptive implant use until 12 weeks after use
Satisfactory of contraceptive implant users
Time Frame: 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
immediately after contraceptive implant use until 12 weeks after use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding status
Time Frame: 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.
immediately after contraceptive implant use until 12 weeks after use
Child weight
Time Frame: 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.
immediately after contraceptive implant use until 12 weeks after use
Child height
Time Frame: 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.
immediately after contraceptive implant use until 12 weeks after use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Study Chair: Unnop Jaisamrarn, M.D., Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

October 15, 2017

First Submitted That Met QC Criteria

November 20, 2017

First Posted (Actual)

November 24, 2017

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sitanan Lertsiripanich

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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