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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chulalongkorn University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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