Visibility of strings after post placental insertion of Cu T 380 A and Cu 375 intra uterine contraceptive device: A randomized comparative study.
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Safdarjung Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Visibility of strings at follow up visits
Study Overview
Brief Summary
Postplacental insertion of Cu375 and CuT380A intra uterine contraceptive device will be done transcesarean within10 minutes after delivery of placenta. Cu T will be inserted using Kelly’sforcep at fundus of uterus and strings will be directed towards the internalos. The women will be observed in post operative ward for 72 hours postinsertion.
Thesubject will be advised to return for scheduled follow up visit at 1 week and 6 weeks post Cu T insertion. At follow upvisit, women will be interviewed in a pre structured proforma about any complaints, menstrualhistory, general physical , pelvic examination will be done, availability ofthread will be noted, requirement of ultrasound or invasive procedure and their findings or anycomplications will be recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Random Number Table
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Women fulfilling following criteria will be eligible for study.
- •1.Women desirous of postpartum contraception for less than or upto 5 years.
- •2.Women posted for elective / emergency caesarean section 3.Women willing to come for follow up.
Exclusion Criteria
- •1.More than 18 hours of rupture of membranes before delivery.
- •2.Any evidence of chorioamnionitis 3.Antepartum hemorrhage or postpartum hemorrhage 4.Fever in recent antepartum period 5.Women in Medical eligibility criteria category 3 or 4 of Copper T insertion.
Outcomes
Primary Outcomes
Visibility of strings at follow up visits
Time Frame: Visibility of strings at 1 week, 6 weeks post cesarean
Secondary Outcomes
- 1.Clinical outcome including pain, bleeding, pelvic infection, expulsion.(2.Requirement of Ultrasound , X- ray, invasive procedure)