CTRI/2011/07/001874招募中3 期
Evaluation of a progesterone vaginal ring as a new contraceptive option in India - PVR study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
研究者
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