Preterm Labor
Conditions
Keywords
cerclage
Brief summary
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.
Interventions
DRUGIndomethacin 150mg
Patients will be randomized to either received perioperative indomethacin or ibuprofen at the time of their emergent cerclage placement for 24 hours following surgery. Patient will be followed up through our electronic medical record system to determine gestational latency to evaluate if ibuprofen is inferior to indomethacin.
DRUGIbuprofen 2400mg
Patients will be randomized to either received perioperative indomethacin or ibuprofen at the time of their emergent cerclage placement for 24 hours following surgery. Patient will be followed up through our electronic medical record system to determine gestational latency to evaluate if ibuprofen is inferior to indomethacin.
Sponsors
Woman's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational latency | From cerclage placement to delivery | Days from cerclage placement to delivery, assessed up to 26 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preterm birth | At delivery | Birth before 37 weeks gestation |
Countries
United States
Outcome results
None listed