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Comparison between mothers at high or low risk of uterine bleeding, with regards to the effective dose of oxytocin during cesarean surgery

Minimum Effective Dose of Oxytocin Bolus during Cesarean Section Delivery: Comparison between Patients at High versus Low Risk of Uterine Atony - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/021901
Enrollment
60
Registered
2019-11-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O721- Other immediate postpartum hemorrhage

Interventions

Intervention1: Group H: Oxytocin, intravenously, at time of umbilical cord clamping, 3 IU dose in first patient, dose in subsequent patients decided by sequential allocation method depending on respon

Sponsors

University College of Mediacl Sciences and GTb Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: >18 years, and posted for cesarean section will be evaluated for inclusion. Those with � 1 risk factor for uterine atony will be included into group H (i.e., high risk group), and with lack of any such factor into group L (i.e., low risk group). The various high-risk factors for uterine atony will include multiple gestation, polyhydramnios, macrosomia, uterine fibroid, previous uterine surgery, abnormal placentation, history of previous uterine atony or PPH, high parity (� 5 previous delivery), chorioamnionitis (fever and on antibiotics for same), magnesium sulfate therapy, or need for general anesthesia.

Exclusion criteria

Exclusion criteria: Exclusion criteria will include patient refusal, active labor ( >3 cm cervical dilation), use of prior oxytocin for labor induction and/or augmentation, pre-eclampsia without magnesium sulfate therapy and absence of any pre-defined high-risk for uterine atony, coagulopathy (thrombocytopenia with platelet count 1.5), as well as history of bleeding disorder or heart disease.

Design outcomes

Primary

MeasureTime frame
Uterine tone (adequate or inadequate)Timepoint: 3 minutes after bolus dose of oxytocin—

Secondary

MeasureTime frame
Side effects that can be attributed to the initial bolus of oxytocin including hypotension, tachycardia (10 bpm), chest pain, flushing, nausea or vomiting, and ST-T changes.Timepoint: Will be noted for upto 5 minutes after the bolus, but prior to any other uterotonic administration including rescue boluses.—

Countries

India

Contacts

Public ContactSonali Deep

University College of Medical Sciences and GTB Hospital

drashatyagi@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026