Impact of Exercise Prescription on Obstetric and Neonatal Outcomes (NCT07678944) | Clinical Trial Compass
CompletedNot Applicable
Impact of Exercise Prescription on Obstetric and Neonatal Outcomes
Portugal310 participantsStarted 2024-02-01
Plain-language summary
The aim of this study is to assess the impact of structured physical activity with smartwatch remote monitoring on glycemic control, blood pressure control, obstetric complications and neonatal outcomes in women with GDM, chronic hypertension and obesity. A prospective, longitudinal, single-arm intervention study with 310 pregnant women was conducted over a period of 18 months. Participants received individualized exercise prescriptions based on international guidelines, complemented by smartwatch monitoring and regular telephonic feedback. Outcomes were compared between subgroups of women who adhere to the recommended exercise guidelines and those who did not, across three high-risk populations (GDM, chronic hypertension and obesity).
Who can participate
Age range
16 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pregnant women aged 16 years or older with a confirmed diagnosis of gestational diabetes (fasting blood glucose greater than 92 mg/dL in first trimester; or values in the oral glucose tolerance test in second trimester greater than 92/180/153 mg/dL, respectively at 0 hours, 1 hour after glucose ingestion, and 2 hours after)
* Pregnant women aged 16 or older with chronic hypertension or a history of bariatric surgery and pre-pregnancy Body Mass Index (BMI) above 30Kg/m2.
* Eligibility further required consistent clinical adherence defined as attending all schedule appointments with the obstetric team without unjustified absences
Exclusion Criteria:
* multiple gestations
* risk of preterm labor
* history of premature delivery due to a non-maternal cause
* persistent vaginal bleeding
* placenta previa beyond 28 weeks' gestation
* cervical insufficiency
* any limiting systemic, respiratory or cardiovascular disease.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Controlled chronic hypertension
Timeframe: From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.
2
Glycemic control
Timeframe: From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.
3
Excessive weight gain
Timeframe: From date of recruitment, usually first apointment, until the date of delivery, assessed up to 32 weeks.