Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-24 @ 12:43 PM
NCT ID:
NCT06249061
Eligibility Criteria:
Inclusion Criteria:
1. Pregnant,
2. Nulliparous,
3. Cephalic presenting,
4. Live, singleton fetus,
5. Planning hospital birth,
6. Under the care of a midwife
7. In spontaneous active labour (with or without cervical ripening), and
8. Greater than or equal to (≥) 37weeks, and 0 days gestation. There is no maximum gestation, so long as the labour was spontaneous
Exclusion Criteria:
1. Planning caesarean birth,
2. Hypertension requiring treatment,
3. Diabetes or gestational diabetes requiring pharmacological treatment,
4. On a low sodium diet,
5. Use of illicit drugs in pregnancy, or
6. Unable to provide informed consent or understand instructions on ingestion of the substance
7. Oxytocin induction of labour, or
8. Oxytocin augmentation of labour prior to randomisation
Healthy Volunteers:
True
Sex:
FEMALE
Study:
NCT06249061
Study Brief:
Protocol Section:
NCT06249061