Mbarara Regional Referral Hospital
Mbarara, Uganda
NCT Number: NCT04060667
To estimate the clinical effectiveness of wireless physiologic monitoring of women in the first 24 hours after cesarean delivery at Mbarara Regional Referral Hospital
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Mbarara, Uganda
Women in sub-Saharan Africa have the highest rates of morbidity and mortality during childbirth. Despite significant increases in facility-based childbirth, quality gaps at the facility have limited reductions in maternal deaths. Infrequent monitoring of women around childbirth is a major gap in care that leads to delays in life-saving interventions. Simple increases in staffing will not overcome this gap, thus necessitating new strategies.
This project aims to use a simple wireless monitor to improve the detection of complications immediately after childbirth and allow clinicians to provide life-saving interventions when needed. Using a hybrid clinical effectiveness-implementation approach women delivered by cesarean in Mbarara, Uganda will be recruited to wear a wireless physiologic monitor for 24 hours after delivery and their delivering obstetricians recruited to use the monitoring system, including the receipt of text message alerts should women develop abnormalities in physiologic signs. Rates of morbidity and mortality will be compared with a control group of women delivered by the same obstetricians. Clinical adoption and implementation will be assessed with the RE-AIM implementation framework and semi-structured interviews.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention in this study is the use of a wireless monitor to perform physiologic monitoring of women undergoing emergency cesarean delivery for the first 24 hours after completion of the cesarean and send alerts to responding clinicians should vital signs fall out of a pre-specified range.
Other names: vital sign abnormality alerts
Time frame: From completion of the cesarean delivery until hospital discharge from the procedure, an average of 3 days
The primary effectiveness outcome was a composite measure of severe maternal morbidity (SMM) measured from enrollment until hospital discharge This composite measure is adapted from World Health Organization (WHO) near-miss morbidity criteria, as well as other severe maternal outcomes, including hysterectomy, cardiac arrest, prolonged unconsciousness, stroke, dialysis, intensive care admission, and death.
Massachusetts General Hospital
Other
Acronym: WIMS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01653392
Abortion, Spontaneous, Birth Weight
San Diego, California, United States
View Trial DetailsNCT07719335
Female Urogenital Diseases and Pregnancy Complications, Pregnancy Complications
Banī Suwayf, Egypt
View Trial DetailsNCT07715422
Female Urogenital Diseases and Pregnancy Complications, Pregnancy Complications
Banī Suwayf, Beni Suweif Governorate, Egypt
View Trial DetailsNCT05576207
Anemia of Pregnancy, Birth Weight
Rangpur City, Bangladesh
View Trial Details