A Phase 4 interventional study of Etonogestrel Drug Implant and Levonorgestrel Drug Implant in Breastfeeding and Post Partum, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-26.
Sponsored by Chulalongkorn University · Phase 4, Interventional, and Treatment
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.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 48-72 hr after child delivery
Drug: Levonorgestrel Drug Implant
Breast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 48-72 hr after child delivery
Drug: Etonogestrel Drug Implant
Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 5-7 weeks after child delivery
Drug: Levonorgestrel Drug Implant
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.
Also known as: Implanon
Levonorgestrel 75 mg (2 rods) are implanted at inner arm of participant.
Also known as: Jadelle
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.
Time frame: 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.
Time frame: 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
Time frame: immediately after contraceptive implant use until 12 weeks after use
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.
Time frame: 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.
Time frame: 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.
Time frame: immediately after contraceptive implant use until 12 weeks after use
Ran from Jan 2018 to primary completion in May 2018, 4 months.
Of 17 phase 4 interventional studies under Breast Feeding, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Etonogestrel · Levonorgestrel