An interventional study of Behavioral Modification Working (BMW) Toolkit and Routine Antenatal Care in Gestational Diabetes Mellitus in Pregnancy and Hypertension ,Pregnancy, sponsored by University of the Punjab. Recruiting at 2 sites in Pakistan. Open to female participants aged 15 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by University of the Punjab · Not applicable, Interventional, and Treatment
This trial aims to evaluate the effectiveness of a Behavioral Modification Working (BMW) Toolkit in improving glycemic control and blood pressure among pregnant women diagnosed with both GDM and PIH.
Gestational diabetes mellitus (GDM) and pregnancy-induced hypertension (PIH) are major contributors to maternal and neonatal morbidity, particularly in low- and middle-income countries. Evidence suggests that lifestyle and self-care interventions focusing on diet, physical activity, and sleep may improve maternal outcomes; however, rigorously designed randomized controlled trials evaluating structured behavioral toolkits in Pakistan are scarce.
262 studies on the registry are indexed under Hypertension, Pregnancy-Induced; 71 are open to participants now.
This study's planned enrollment of 220 is above the median of 147 across 174 interventional studies indexed under Hypertension, Pregnancy-Induced.
Browse Hypertension, Pregnancy-Induced studies →University of the Punjab is the lead sponsor of 20 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants receive the Behavioral Modification Working (BMW) Toolkit in addition to routine antenatal care. The intervention includes 7-8 structured sessions delivered by a trained health educator focusing on dietary modification, physical activity, sleep hygiene, and self-care practices during pregnancy.
Behavioral: Behavioral Modification Working (BMW) Toolkit
Participants receive routine antenatal care according to standard hospital practice for management of gestational diabetes mellitus and pregnancy-induced hypertension without the BMW Toolkit intervention.
Other: Routine Antenatal Care
Structured behavioral intervention consisting of 7-8 sessions delivered by a trained health educator focusing on dietary modification, physical activity promotion, sleep hygiene, and self-care practices for pregnant women with gestational diabetes mellitus and pregnancy-induced hypertension, provided in addition to routine antenatal care.
Also known as: BMW Toolkit
Standard antenatal care provided according to hospital protocol for gestational diabetes mellitus and pregnancy-induced hypertension.
Fasting Blood Glucose
Fasting blood glucose concentration (mg/dL or mmol/L, according to site laboratory standard) will be measured at baseline and at follow-up. The outcome measure is the change from baseline to 40 weeks gestation, compared between study groups.
Time frame: Baseline and 40 weeks gestation
Blood Pressure
Systolic and diastolic blood pressure (mmHg) measured at baseline and follow-up. Outcome is change from baseline to 36 weeks gestation compared between study groups.
Time frame: Baseline and 36 weeks gestation
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in the primary and secondary outcome analyses will be made available to researchers upon reasonable request. Shared data will include demographic, clinical (fasting blood glucose, systolic/diastolic blood pressure), maternal outcomes (e.g., preeclampsia, mode of delivery), neonatal outcomes (e.g., birth weight, gestational age), and knowledge/self-care practice scores. The study protocol, statistical analysis plan, and informed consent form will also be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will become available starting 6 months after publication of the primary trial results and will remain available for 5 years.
Access criteria: Access will be granted to researchers who submit a methodologically sound proposal with a clear research question, approved by the principal investigator and the Punjab University Institutional Ethics Review Board. A signed data access agreement ensuring confidentiality and appropriate use is required.
Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 8 months after the start.
Of 90 non-industry interventional studies with no phase under Hypertension, Pregnancy-Induced, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 8 months is below that.
Counting every sponsor, half of 91 studies reached it within 23 months; a quarter within 9 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hypertension, Pregnancy-Induced →
University of the Punjab