Helping Mothers Select Better Childbirth Hospitals

Status Completed

Clinical Trial Summary

The investigators aim to conduct a randomized controlled trial of women who are pregnant or considering pregnancy to understand whether women provided with specific data on hospital-level cesarean delivery rates are more likely to select higher quality hospitals, defined as hospitals with cesarean delivery rates below the Federal HealthyPeople 2020 target of 23.9%.

Clinical Trial Description

The choice of a childbirth provider is one of the most consequential decisions a pregnant woman makes. The hospital she delivers at is a better predictor of many treatment decisions than her own risks or preferences. For example, choosing the wrong hospital can increase the risk of cesarean delivery up to 10-fold. Cumulatively, avoidable cesarean deliveries are estimated to cause 20,000 major surgical complications, $5 billion in spending, and unmeasured pain each year in the United States. The proposed project aims to prevent these harms by empowering women to choose hospitals with risk-appropriate cesarean delivery rates. Preliminary research indicates that the majority of women may not understand how hospital-level quality data applies to them personally. In a test sample of 1,000 demographically diverse pregnant mothers, over half do not know if hospital-level cesarean delivery rates are important, and the overwhelming majority do not know if obstetrical infection rates, maternal or neonatal birth trauma rates, or hospital quality metrics are important when selecting their hospital. The investigators will conduct a randomized controlled trial of women using Ovia Health mobile applications to track their fertility or pregnancy to understand whether women provided with location-specific cesarean delivery rate data along with education about the importance of hospital-level cesarean delivery rates are more likely to select higher quality hospitals than women provided with education alone. The study is labeled double blind, but the investigators recognize uncertainty on this framework. Though subjects will be exposed to different information they do not know they were in a trial. At the point that outcomes are collected, researchers will not know which group the subject was randomized because outcomes are self-reported. ;

Study Design

Related Conditions & MeSH terms

Cesarean Section

Clinical Trial Details

NCT number	NCT02987803
Study type	Interventional
Source	Harvard School of Public Health (HSPH)
Contact
Status	Completed
Phase	N/A
Start date	August 15, 2019
Completion date	June 30, 2021

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT03631329` - Predictability of Preoperative Carotid Artery Corrected Flow Time for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section
Completed	`NCT03244540` - Regional Analgesia After Cesarean Section	Phase 4
Active, not recruiting	`NCT03760718` - Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery	Early Phase 1
Active, not recruiting	`NCT04965779` - The Effect of Abdominal Binder Use on Postpartum Pain, Bleeding, and Breastfeeding Success in Cesarean Delivery Women	N/A
Terminated	`NCT01687972` - INSORB Versus Subcuticular Sutures at Cesarean Section	Phase 1
Withdrawn	`NCT01211431` - Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine	Phase 4
Completed	`NCT00987701` - Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors	N/A
Completed	`NCT00991627` - Different Approaches to Maternal Hypotension During Cesarean Section	Phase 4
Completed	`NCT01049477` - The Effects of Music Therapy on Women's Anxiety Before and During Cesarean Delivery	N/A
Terminated	`NCT00524511` - Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples	N/A
Terminated	`NCT00386477` - Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial	N/A
Completed	`NCT00375986` - A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section	N/A
Completed	`NCT00517140` - Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function	N/A
Terminated	`NCT05051150` - Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Caesarean Section	Phase 4
Terminated	`NCT03695172` - Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section	Phase 4
Recruiting	`NCT06247852` - Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Completed	`NCT06012747` - Pain After Cesarean Section - A Danish Multicenter Cohort Study.
Not yet recruiting	`NCT05187520` - Naldebain for Control of Post-Cesarean Section Pain	Phase 2
Not yet recruiting	`NCT04999670` - Fascial Closure and Post-caesarean Pain	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.