Heat adaptation for pregnant women and infants

Co-produced, complex heat adaptation interventions to reduce heat impacts on pregnant women and newborns in Southern Africa: an intervention development and feasibility evaluation study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10215046

Enrollment

800

Registered

2025-06-10

Start date

2024-12-19

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal dehydration and heat-related health complications Pregnancy and Childbirth

Interventions

This is a non-randomised, quasi-experimental pre-post interventional study designed to evaluate the feasibility, acceptability, scalability, and pilot effectiveness of a multi-level, multi-component h

Eligibility

Sex/Gender

Female

Age

16 Years to 49 Years

Inclusion criteria

Inclusion criteria: 1. Pregnant, with a gestational age between 26 and 30 weeks at the time of enrolment 2. Aged 16 years or older at the time of providing consent 3. Intending to give birth at a participating health facility within Mt Darwin District (Mt Darwin District Hospital, Chitse Rural Clinic, or Dotito Rural Clinic) 4. Not currently experiencing serious complications of pregnancy that have required hospitalisation 5. Residing within the catchment area of one of the participating facilities 6. Willing and able to provide written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Women who are not pregnant at the time of screening 2. Pregnant women with a gestational age below 26 weeks or above 30 weeks at enrolment 3 . Pregnant girls under the age of 16 at the time of consent 4. Women not intending to give birth at any health facility within Mt Darwin District 5. Women with serious pregnancy-related complications requiring current or prior hospitalisation (e.g., severe pre-eclampsia, antepartum haemorrhage) 6. Individuals unable or unwilling to provide written informed consent

Design outcomes

Primary

Measure	Time frame
Mild-to-moderate hypovolemic maternal dehydration is measured using urine specific gravity (USG >1.015), assessed using validated digital handheld refractometers, including the ATAGO PAL-10S (Cat. No. 4410), at enrolment (26–30 weeks’ gestation), at a 4-week antenatal care follow-up visit, during labour, and within 72 hours postpartum (with follow-up window extended to a maximum of 10 days postpartum for participants not seen within 72 hours).	—

Measure

Time frame

Mild-to-moderate hypovolemic maternal dehydration is measured using urine specific gravity (USG >1.015), assessed using validated digital handheld refractometers, including the ATAGO PAL-10S (Cat. No. 4410), at enrolment (26–30 weeks’ gestation), at a 4-week antenatal care follow-up visit, during labour, and within 72 hours postpartum (with follow-up window extended to a maximum of 10 days postpartum for participants not seen within 72 hours).

—

Secondary

Measure	Time frame
1. Heat strain (physiological) is measured using skin temperature, assessed with validated non-contact infrared thermometers at enrolment (26–30 weeks’ gestation), at least one 4-weekly antenatal care follow-up visit, during labour, and within 72 hours postpartum (with follow-up window extended to a maximum of 10 days postpartum for participants not seen within 72 hours). Mean values will be analysed to compare physiological heat stress between the pre- and post-intervention cohorts. 2. Maternal psychological wellbeing is measured using three validated instruments: the Women’s Wellbeing and Capability Index (WWCI), the EQ-5D-5L (including the EQ-VAS and overall health state score), and the Perceived Stress Scale (PSS-10). The WWCI is a multidimensional, culturally adapted questionnaire assessing domains such as physical strength, time autonomy, emotional wellbeing, rest, future optimism, caregiving capacity, safety, social support, financial resilience, and housing adequacy. All three instruments are administered at enrolment (26–30 weeks’ gestation), at least one antenatal care follow-up visit, and at the postpartum visit (within 72 hours postpartum, with follow-up window extended to a maximum of 10 days postpartum for participants not seen within 72 hours). Scores from each instrument will be analysed independently and compared between pre- and post-intervention cohorts. 3. Maternal composite clinical outcome is measured as the occurrence of one or more obstetric complications — obstetric emergencies, emergency Caesarean section, pre-eclampsia/eclampsia, antepartum haemorrhage, postpartum haemorrhage, or maternal sepsis — as diagnosed by the attending clinician and recorded in routine maternal case records at the time of delivery and/or at the postpartum visit (within 72 hours postpartum, with follow-up window extended to 10 days postpartum for participants not seen within 72 hours). The proportion of participants experiencing at least one complication will be com	—

Measure

Time frame

1. Heat strain (physiological) is measured using skin temperature, assessed with validated non-contact infrared thermometers at enrolment (26–30 weeks’ gestation), at least one 4-weekly antenatal care follow-up visit, during labour, and within 72 hours postpartum (with follow-up window extended to a maximum of 10 days postpartum for participants not seen within 72 hours). Mean values will be analysed to compare physiological heat stress between the pre- and post-intervention cohorts. 2. Maternal psychological wellbeing is measured using three validated instruments: the Women’s Wellbeing and Capability Index (WWCI), the EQ-5D-5L (including the EQ-VAS and overall health state score), and the Perceived Stress Scale (PSS-10). The WWCI is a multidimensional, culturally adapted questionnaire assessing domains such as physical strength, time autonomy, emotional wellbeing, rest, future optimism, caregiving capacity, safety, social support, financial resilience, and housing adequacy. All three instruments are administered at enrolment (26–30 weeks’ gestation), at least one antenatal care follow-up visit, and at the postpartum visit (within 72 hours postpartum, with follow-up window extended to a maximum of 10 days postpartum for participants not seen within 72 hours). Scores from each instrument will be analysed independently and compared between pre- and post-intervention cohorts. 3. Maternal composite clinical outcome is measured as the occurrence of one or more obstetric complications — obstetric emergencies, emergency Caesarean section, pre-eclampsia/eclampsia, antepartum haemorrhage, postpartum haemorrhage, or maternal sepsis — as diagnosed by the attending clinician and recorded in routine maternal case records at the time of delivery and/or at the postpartum visit (within 72 hours postpartum, with follow-up window extended to 10 days postpartum for participants not seen within 72 hours). The proportion of participants experiencing at least one complication will be com

—

Countries

Zimbabwe

Contacts

Public ContactFortunate Machingura

fortunate.machingura@ceshhar.org+263 (0)772971481

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026