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A randomised controlled trial of intravenous versus intramuscular oxytocin in the management of third stage of labor.

Intravenous versus intramuscular oxytocin in the management of third stage of labor for prevention of postpartum hemorrhage.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000624886
Enrollment
450
Registered
2012-06-12
Start date
2012-06-15
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Postpartum hemorrhage (PPH) is a significant cause of maternal morbidity and mortality throughout the world especially in developing countries. Uterine atony is the most common etiology. The incidence of postpartum hemorrhage was 3.9% in women delivered vaginally. Active management in third stage of labor is accepted protocol to prevent postpartum hemorrhage. Active management in third stage of labour involves giving a prophylactic uterotonic drug, controlled cord traction to deliver the placenta and uterine massage. Routine oxytocin has been well established. Synthetic oxytocin, acts on the smooth muscle of the uterus to stimulate contractions; especially after term, when adequate oxytocin receptors. When oxytocin binds to oxytocin receptors induces increase intracellular Ca2+ releasing and the increased prostaglandin secretion all contribute to the contractile effects and inhibition of Gamma-Aminobutyric acid (GABA) receptors (this would depolarize if GABA acts as a tonic inhibitory modulator) also causes responses contractions of the uterus. Oxytocin use is advocated either intramuscularly (10 IU) or as a dilute infusion, intravenous bolus has also been used by other authors and they showed an IV bolus of oxytocin 5 to 10 IU, can be used for postpartum hemorrhage prevention after vaginal birth but is not recommended in case of elective cesarean section. At Khon Kaen Hospital guideline recommended 10 units intramuscular oxytocin for routine prophylaxis postpartum hemorrhage. The data of all deliveries in 2010 were collected .We found that postpartum hemorrhage rate 3 % follow vaginal delivery. No maternal death caused from postpartum hemorrhage . We therefore would like to conduct randomized controlled trial to compare the efficacy and safety of intravenous versus intramuscular oxytocin in the management of third stage of labor.

Interventions

Arm1: Intravenous oxytocin injection 10 units immediately after delivery of the newborn

Sponsors

Khon Kaen Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes

Inclusion criteria

. Singleton pregnancy with spontaneous vertex delivery . Gestational age at least 34 weeks . Parity < 5

Exclusion criteria

. Cesarean section . High risk postpartum hemorrhage ; - Pregnancy induced hypertension (PIH) , - multifetal pregnancy , polyhydramnios , macrosomia , - Placenta previa ,Placental abruption ,Placenta accreta/increta/percreta - hematologic problems: thrombocytopenia, coagulopathy - Obesity ( BMI >29 ) ,Previous postpartum hemorrhage . Previous history of curettage . Previous manual removal of placenta . Cardiovascular instability . Under anesthesia . Oxytocin hypersensitivity . Medical problem: Diabetes mellitus (DM) , nephrotic syndrome , renal insufficiency ,sepsis

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026