Preterm LaborTOCONCT04726085
Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement
A study testing Indomethacin 150mg and Ibuprofen 2400mg in people with Preterm Labor, run by Woman's at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor
- What is being tested?
- Indomethacin 150mg and Ibuprofen 2400mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 6 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ibuprofen Versus Indomethacin as Perioperative Prophylactic Treatment Following Emergent Cerclage Placement for Pregnancy Prolongation: A Randomized Controlled Trial
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.
- Conditions
- Preterm Labor
- Being tested
- Indomethacin 150mg, Ibuprofen 2400mg
- Keywords
- cerclage
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indomethacin 150mgDrug
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.
Ibuprofen 2400mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Active comparator | Ibuprofen 600 mg q6 hours for 24 hours- total dose of 2400mg- after emergent cerclage placement Receives: Drug: Ibuprofen 2400mg |
| Indomethacin | Active comparator | Indomethacin 50 mg q8 hours for 24 hours- total dose of 150mg- after emergent cerclage placement Receives: Drug: Indomethacin 150mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational latency
Days from cerclage placement to delivery, assessed up to 26 weeks
Measured: From cerclage placement to delivery
Secondary outcomes (1)
Preterm birth
Birth before 37 weeks gestation
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Feb 2021
- Primary completion6 Nov 2023
- Study completion6 Nov 2023
Why it stopped: Investigative team moved institutions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela Simmons, DO, Principal investigator, Woman's Hospital, Louisiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726085
- Sponsor's protocol ID
- RP-20-028
- Acronym
- TOCO
- Status last verified
- Aug 2025
- First submitted
- 19 Jan 2021
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ibuprofen Versus Indomethacin as Perioperative Prophylactic Treatment Following Emergent Cerclage Placement for Pregnancy Prolongation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04726085
- Acronym / sponsor ID
- TOCO / RP-20-028
- Conditions
- Preterm Labor
- Keywords
- cerclage
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigative team moved institutions
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Woman'sUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Active comparator | Drug: Ibuprofen 2400mgIbuprofen 600 mg q6 hours for 24 hours- total dose of 2400mg- after emergent cerclage placement |
| Indomethacin | Active comparator | Drug: Indomethacin 150mgIndomethacin 50 mg q8 hours for 24 hours- total dose of 150mg- after emergent cerclage placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indomethacin 150mgPatients 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. | Drug | Indomethacin |
| Ibuprofen 2400mgPatients 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. | Drug | Ibuprofen |
Primary outcome
Gestational latency
Time frame: From cerclage placement to delivery
Days from cerclage placement to delivery, assessed up to 26 weeks
1 secondary outcome
Preterm birth
Time frame: At delivery
Results and safety
The study was stopped early (reason given: Investigative team moved institutions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Preterm Labor
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Simmons, DO principal investigator
Woman's Hospital, Louisiana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indomethacin 150mg and Ibuprofen 2400mg in people with Preterm Labor, run by Woman's at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigative team moved institutions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational latency (time frame: From cerclage placement to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.