None listed
Conditions
Interventions
Intervention1: Progesterone Vaginal Ring: PVR is comprised of a homogeneous distribution of progesterone (22.5% on a weight/weight basis
2 gram total) in a silastic elastomer.It releases progesterone at an average rate of 10 mg per day over a 3-month (90-day) period maintaining the blood levels of progesterone to 10-25 nmol/L. Women en
Sponsors
Indian Council of Medical Research
Population Council USA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Able to provide informed consent 2. Age 20 to 35 years (inclusive) 3. Delivered a healthy singleton infant 6 to 9 weeks prior to study enrollment 4. Has at least one (1) living child and is exclusively breastfeeding the new infant (no supplementary feedings) 5. The new breast fed infant?s weight is more than -2SD as per WHO weight for age standards 6. Experienced a normal post partum period 7. Is in good health as confirmed by medical history, physical examination (including vital signs), pelvic/breast examination, and results of laboratory tests at the screening visit 8. Willing to continue breastfeeding at least for one year 9. Has or expects to have regular exposure to the risk of pregnancy 10. Not currently using any method of contraception including barrier or conventional (abstinence, withdrawal, safe period) methods 11. Willing to be counseled on all methods of contraception & choose one study method (PVR/IUD) 12. Willing and able to follow study procedures & come to study center for study visits as described in the protocol 13. Expects to continue living in an area accessible to the study center for the duration of the study
Exclusion criteria
Exclusion criteria: 1. Are pregnant or are suspected of being pregnant 2. Giving supplementary feeds to the new infant 3. Clinically relevant genital prolapse 4. Had postpartum endometritis or puerperal sepsis 5. Had pelvic inflammatory disease or salpingitis since delivery 6. Are hypersensitive to hormonal preparations or silicone rubber 7. History of generalized urticaria 8. Any chronic condition requiring continuous or regular use of medication 9. Known or suspected diabetes or thyroid disease 10. History of thrombophlebitis or thromboembolism 11. Has a cerebrovascular disorder or coronary artery disease 12. History of and/or current incapacitating migraine 13. Confirmed hypertension or a history of severe pre-eclampsia 14. Neurovascular lesion of the eye or serious visual disturbance at screening 15. History of and/or current depression 16. History of epilepsy or convulsive disorder 17. Known or suspected hepatic adenomas or carcinomas 18. Had an ectopic pregnancy 19. Untreated acute cervicitis or vaginitis 20. Has vaginal bleeding not attributable to menses 21. Current Pap smear suggestive of high-grade pre-cancerous lesion(s), including HGSIL, CIN I and moderate or severe dysplasia 22. Known or suspected uterine or cervical malignancy 23. Known or suspected carcinoma of the breast 24. Has any other known or suspected neoplasia 25. Not cohabiting (not exposed to risk of pregnancy) 26. History of hepatitis or pregnancy-related jaundice 27. History of chronic constipation (for women who choose PVR only) 28. Use of chronic medications, Rifampicin, Griseofluvin, barbiturates, phenytoin, ketoconozole, butazoliden 29. Hemoglobin less than 8 g/dl (colorimeter method for cynmeth Hemoglobin ) 30. Urine for albumin, sugar and microscopic examination indicates abnormal results 31. Blood Pressure- systolic more than 130 mm Hg and/or diastolic more than 85 mm Hg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To confirm the contraceptive safety [inclusive of reports of adverse events (AEs) and serious adverse events (SAEs), results of medical examinations and laboratory safety studies] and efficacy (failure rate) of the progesterone vaginal ring (PVR) as compared to the Copper T 380A IUD in breastfeeding women during the first postpartum year. 2. To confirm and compare the continuation rate of PVR and the IUD in breastfeeding women during the first postpartum year. Timepoint: First postpartum year. | — |
Secondary
| Measure | Time frame |
|---|---|
| 7. health care providersâ?? knowledge and attitudes about the methods and their use 8. factors influencing acceptability and perception of PVR and Copper T 380A 9. establish training in Good Clinical Practice and safety reporting 10. If results of the study are favorable, to assist in the transfer of PVR technology at the production scale to HLL in Trivandrum, India Timepoint: First postpartum year;1. infant growth (weight, length, WHO growth curve) 2. vaginal bleeding patterns (bleeding/spotting episodes) 3.duration of lactational amenorrhea 4. number of breastfeeding episodes, duration of full/partial nursing 5. tolerability (use problems, vaginal problems) 6. factors influencing decision making by nursing mothers to participate in a study with PVR, an investigational new contraceptive option, and the existing method Copper T 380A Timepoint: First postpartum year | — |
Countries
India
Contacts
Public ContactDr Malabika Roy
Indian Council of Medical Research (ICMR)
Outcome results
None listed