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

â??Comparison of the expulsion rate of intra uterine contraceptive device Cu T 375 and Copper T 380 A after post placental and early postpartum insertion- A randomized control trialâ??

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026357

Enrollment

396

Registered

2020-07-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Cu T 375: Copper T 375 Control Intervention1: Cu T 380A: Cu T 380A

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

India

Contacts

Public ContactNitesh C

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR

sharma.charu651@gmail.com7063956215

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026