A randomized control trial to compare the expulsion rate of Cu T 375 and Cu T 380 A

Phase 1

• Conditions: Health Condition 1: O80- Encounter for full-term uncomplicated delivery

• Registration Number: CTRI/2020/07/026357
• Lead Sponsor: ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021
• Study Completion: 2021-12-28

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 396

Inclusion Criteria

1.All Postpartum women delivering in our institute either vaginally or by caesarean section who fulfills the medical eligibility criteria for Cu T insertion (10).

2.Those women consenting to participate in the study and willing to come for follow up

Exclusion Criteria

1.Women with history of Sexually transmitted diseases or pelvic inflammatory diseases, coagulation disorders, liver or renal dysfunction, Diabetes Mellitus or Wilsons disease.

2.Intrapartum and recent antepartum fever (within 7 days), puerperal sepsis, postpartum haemorrhage, rupture of membranes for greater than 18 hours prior to delivery.

3.Women with pre-existing gynecological cancers

4.Women with uterine anomalies or leiomyoma distorting the shape of uterine cavity.

5.Previous 2 LSCS

6.Patients not giving consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To see for expulsion rates of both the types of Copper T within 6 weeks after insertion.Timepoint: To see for expulsion rates of both the types of Copper T within 6 weeks after insertion.

Secondary Outcome Measures

Name	Time	Method
1.To look for any difference in the expulsion rate of Cu T IUD inserted after vaginal delivery and after caesarean section within 6 weeks.Timepoint: at 6 weeks;2.To look for any difference in the expulsion rate of Cu T IUD inserted post placental or early post-partum i.e. (within 48 hoursof delivery) during 6 weeks follow up.Timepoint: 6 weeks;3.To see for complications like abdominal pain, irregular bleeding,uterine perforation.Timepoint: at 6 weeks;Missing copper T threads.Timepoint: at 6 weeks;Pelvic inflammation disease.Timepoint: at 6 weeks.