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NCT02152735 · ClinicalTrials.gov registry record · NA
Intrauterine Cleaning After Placental Delivery at Cesarean Section: RCT
A NA study, sponsored by Michigan State University.
- Completed
- Registry status
- NA
- Development phase
- 206
- Enrollment target
NCT02152735: Completed NA study, sponsored by Michigan State University.
NCT02152735 is a NA study that has completed, run by Michigan State University. The registered enrollment target is 206 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02152735, a NA study, has completed, sponsored by Michigan State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 206 participants
- Enrollment target
Study Summary
PURPOSE: To test the hypothesis that omission of intrauterine cleaning during cesarean deliveries does not increase intraoperative and postoperative complications. METHODS: We plan to randomize 206 women undergoing primary and repeat cesarean deliveries to cleaning (n=103) versus no cleaning (n=103) of the uterine cavity following placental delivery. Women will be excluded if any of the following criteria are encountered: preterm premature rupture of membranes, spontaneous rupture of membranes prior to cesarean section, chorioamnionitis, fetal demise, uncontrolled diabetes or an immunosuppressive disorder. Primary outcome measure will be endo-myometritis after delivery. Secondary outcomes will include post partum hemorrhage, mean surgical time, retained products of conception, retained placenta, quantitative blood loss, length of hospital stay, return of gastrointestinal function, repeat surgery, and hospital readmission rates. Analysis will follow the intention-to-treat principle. GENERAL DESIGN All eligible patients who are scheduled for cesarean section at the Sparrow hospital/Michigan State University Resident OBGYN and Perinatology clinics will be evaluated for study inclusion. Patients meeting this study's inclusion criteria and lack exclusion criteria will be approached for consent and enrollment.
Primary Outcome
Endomyometritis will be diagnosed by the presence of two or more of the following: abnormally tender uterus on examination, temperature more than 38.0°C at any time postoperatively, and unexplained maternal tachycardia more than 100 beats per minute (bpm). A diagnosis of endomyometritis will be criteria for initiating treatment with antibiotics.
Interventions
- PROCEDURE Cleaning the uterine cavity
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2014-07 |
| Est. Completion | 2015-11 |
| Phase | NA |
What the finished NCT02152735 record still lists
NCT02152735 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Cleaning the uterine cavity is the first listed.
NCT02152735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02152735 about?
NCT02152735 is a clinical study titled "Intrauterine Cleaning After Placental Delivery at Cesarean Section: RCT". PURPOSE: To test the hypothesis that omission of intrauterine cleaning during cesarean deliveries does not increase intraoperative and postoperative complications. METHODS: We plan to randomize 206 women undergoing primary and repeat cesarean deliveries to cleaning (n=103) versus no cleaning (n=1...
What is the current status of trial NCT02152735?
This trial is currently completed. It is a NA study. The enrollment target is 206 participants. The study started on 2014-07. Estimated completion is 2015-11.
What interventions are being tested in trial NCT02152735?
The interventions under investigation include: Cleaning the uterine cavity (PROCEDURE).
Who is sponsoring clinical trial NCT02152735?
This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02152735's enrollment target sits among peer trials
206 499th of 2000 higher than 1,502 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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