Post partum haemorrhage (PPH) prevention: oxytocin pharmacokinetics and maternal body mass index (BMI).

Phase 4

• Conditions: Postpartum haemorrhage; Overweight and obesity; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12617000176369
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-02
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

1) A Body Mass Index (BMI) classified as either: normal range, (BMI 18.5-24.99 Kg/m2), overweight/pre-obese (BMI 25.00-29.99 Kg/m2), obese class I (BMI 30-34.99 Kg/m2) obese class II (BMI 35-39 Kg/m2) or obese class III (equal to, or more than, 40.00 Kg/m2), at booking
2) Singleton pregnancy
3) Live fetus
4) Full term pregnancy (equal to, or more than, 37 weeks)
5) Mode of birth: elective lower segment caesarean section (LUSCS) (no labour) or a vaginal birth (following labour)
6) Parity: 3, or less, at time of recruitment (antenatal)
7) Haemoglobin (Hb) equal to, or more than, 100g/L
8) 18-40 years of age
9) Capacity to provide written, informed consent.

Exclusion Criteria

1) A Body Mass Index (BMI) classified as either: underweight <18.5 Kg/m2, at booking
2) Prior to birth, where it is already known that there will be a clinical indication for the administration of Syntometrine ('Registered Trademark') and/or Ergometrine for the routine management of the third stage of labour
3) A diagnosis of Type I insulin dependent diabetes (IDDM)
4) General anaesthesia for caesarean section
5) A recipient of an intra-partum oxytocin intravenous infusion (IVI)
6) A requirement for an emergency caesarean section
7) <37 completed weeks of pregnancy
8) Previous hypersensitivity/adverse reaction to oxytocin (Syntocinon 'Registered Trademark') or any of the excipients in its formulation
9) Evidence of hepatic or renal dysfunction, demonstrated by abnormalities in pathology reports and/or documentation in hospital records
10) The presence of hypertension requiring IV therapy
11) Presence of maternal cardiac disease/arrhythmias, where a reduced dose of oxytocin maybe advocated
12) Unwillingness or inability to follow the procedures outlined in the Participant Information and Consent Form
13) Mentally, cognitively or legally incapacitated or unable to provide informed consent
14) Co-recruitment/participation in another clinical trial where there is pharmaceutical intervention
15) Documented, or declared, use of: methadone, buprenorphine and/or illegal drugs during pregnancy
16) Presence of (any/all): Hepatitis B Surface Antigen (HBsAg), positive Hepatitis C Antibody Test or Human Immunodeficiency Virus (HIV) Antibody
17) Known abnormality of placentation (e.g. placenta praevia, vasa praevia, placental abruption, placenta accreta/incretta/percreta).

Study & Design

• Study Type: Interventional
• Study Design: Not specified