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Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03353012
Recruitment Status : Completed
First Posted : November 24, 2017
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Chulalongkorn University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breastfeeding Post Partum Drug: Etonogestrel Drug Implant Drug: Levonorgestrel Drug Implant Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: Implanon


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353012


Locations
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Thailand
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
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Study Chair: Unnop Jaisamrarn, M.D. Chulalongkorn University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03353012    
Other Study ID Numbers: Sitanan Lertsiripanich
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chulalongkorn University:
Immediate postpartum implant
postpartum implant
implant contraception
Etonogestrel
Levonorgestrel
Additional relevant MeSH terms:
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Levonorgestrel
Etonogestrel
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
 Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral