Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement (TOCO)

Woman's logo

Woman's

Status

Invitation-only

Conditions

Preterm Labor

Treatments

Drug: Indomethacin 150mg
Drug: Ibuprofen 2400mg

Study type

Interventional

Funder types

Other

Identifiers

NCT04726085
RP-20-028

Details and patient eligibility

About

Cervical insufficiency is defined as painless cervical dilation in the second trimester. Cervical insufficiency can ultimately lead to second trimester loss of pregnancy. Cerclages are utilized in pregnancies affected by cervical insufficiency in order to prolong gestational latency. There have been several studies investigating the efficacy of perioperative medications for cerclage placement and the effects they have on gestational latency. Some such studies have found that perioperative indomethacin in combination with antibiotics have significantly increased gestational latency when compared to placebo. Indomethacin has traditionally been the tocolytic of choice with cerclage placement. At our hospital, ibuprofen has been the tocolytic of choice for cerclage placement secondary to pharmacy availability. Our study aims to evaluate whether gestational latency differs among patients undergoing emergent cerclage whether they receive perioperative ibuprofen or indomethacin.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Viable, singleton pregnancy
  • ≥ 18 years old
  • Gestational age 16 weeks 0/7 days - 23 week 6/7 days (inclusive)
  • Intact membranes at time of enrollment
  • Planning to deliver at Woman's Hospital
  • Exam or ultrasound indicated cerclage placement

Exclusion criteria

  • Contraindication to treatments (i.e. ibuprofen or indomethacin)
  • Unwilling to be randomized to treatment
  • Prophylactic cerclage placement
  • Temperature greater than 100.4
  • Known major fetal congenital anomaly
  • Prior cerclage placement during the current pregnancy
  • Recent (within 7 days) receipt of ibuprofen or indomethacin

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Ibuprofen
Active Comparator group
Description:
Ibuprofen 600 mg q6 hours for 24 hours- total dose of 2400mg- after emergent cerclage placement
Treatment:
Drug: Ibuprofen 2400mg
Indomethacin
Active Comparator group
Description:
Indomethacin 50 mg q8 hours for 24 hours- total dose of 150mg- after emergent cerclage placement
Treatment:
Drug: Indomethacin 150mg

Trial contacts and locations

0

Loading...

Central trial contact

Pamela Simmons, DO; Ericka Seidemann

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems