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Completed

NCT Number: NCT03353012

Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior Post Partum

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 10330, Thailand

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Etonogestrel Drug Implant

Drug

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

Other names: Implanon

Levonorgestrel Drug Implant

Drug

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

Other names: Jadelle

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 24, 2017
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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