Evaluation of Progesterone vaginal ring v/s Cu T 380 A IUD in lactating wome

Phase 3

• Registration Number: CTRI/2011/07/001874
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 1600

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified