BreastfeedingPhase 4NCT03353012
Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant
A Phase 4 study testing Etonogestrel Drug Implant and Levonorgestrel Drug Implant in people with Breastfeeding and Post Partum, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Post Partum
- What is being tested?
- Etonogestrel Drug Implant and Levonorgestrel Drug Implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2018to 1 Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Breast-feeding post-partum woman aged 18-45 years who wish to use contraceptive implant
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 10330
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.
Read the 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
- Conditions
- Breastfeeding, Post Partum
- Being tested
- Etonogestrel Drug Implant, Levonorgestrel Drug Implant
- Keywords
- Immediate postpartum implant, postpartum implant, implant contraception, Etonogestrel, Levonorgestrel
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etonogestrel Drug ImplantDrug
Also called Implanon
Etonogestrel 68 mg (single rod) is implanted at inner arm of participant.
Levonorgestrel Drug ImplantDrug
Also called Jadelle
Levonorgestrel 75 mg (2 rods) are implanted at inner arm of participant.
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel immediate post-partum | Experimental | Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 48-72 hr after child delivery Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Etonogestrel Drug Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: immediately after contraceptive implant use until 12 weeks after use
Secondary outcomes (3)
Breastfeeding status
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.
Measured: immediately after contraceptive implant use until 12 weeks after use
Child weight
To compare child growth by measuring weight, between Immediate and delayed breastfeeding postpartum contraceptive users.
Measured: immediately after contraceptive implant use until 12 weeks after use
Child height
To compare child growth by measuring height, between Immediate and delayed breastfeeding postpartum contraceptive users.
Measured: immediately after contraceptive implant use until 12 weeks after use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Jan 2018
- Primary completion1 May 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Unnop Jaisamrarn, M.D., Study chair, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353012
- Sponsor's protocol ID
- Sitanan Lertsiripanich
- Status last verified
- Oct 2017
- First submitted
- 15 Oct 2017
- Last updated
- 26 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36302159
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant
- ClinicalTrials.gov ID
- NCT03353012
- Acronym / sponsor ID
- Sitanan Lertsiripanich
- Conditions
- Breastfeeding, Post Partum
- Keywords
- Immediate postpartum implant, postpartum implant, implant contraception, Etonogestrel, Levonorgestrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Levonorgestrel immediate post-partum | Experimental | Drug: Levonorgestrel Drug ImplantBreast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 48-72 hr after child delivery |
| Etonogestrel immediate post-partum | Experimental | Drug: Etonogestrel Drug ImplantBreast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 48-72 hr after child delivery |
| Levonorgestrel delayed post-partum | Active comparator | Drug: Levonorgestrel Drug ImplantBreast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 5-7 weeks after child delivery |
| Etonogestrel delayed post-partum | Active comparator | Drug: Etonogestrel Drug ImplantBreast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 5-7 weeks after child delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Breast-feeding post-partum woman aged 18-45 years who wish to use contraceptive implant
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etonogestrel Drug ImplantAlso: ImplanonEtonogestrel 68 mg (single rod) is implanted at inner arm of participant. | Drug | Etonogestrel delayed post-partum, Etonogestrel immediate post-partum |
| Levonorgestrel Drug ImplantAlso: JadelleLevonorgestrel 75 mg (2 rods) are implanted at inner arm of participant. | Drug | Levonorgestrel delayed post-partum, Levonorgestrel immediate post-partum |
Primary outcome
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.
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.
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
3 secondary outcomes
Breastfeeding status
Time frame: immediately after contraceptive implant use until 12 weeks after use
Child weight
Time frame: immediately after contraceptive implant use until 12 weeks after use
Child height
Time frame: immediately after contraceptive implant use until 12 weeks after use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Derived from this study: PubMed 36302159Sothornwit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Unnop Jaisamrarn, M.D. study chair
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etonogestrel Drug Implant and Levonorgestrel Drug Implant in people with Breastfeeding and Post Partum, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events (time frame: immediately after contraceptive implant use until 12 weeks after use). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03353012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.