NCT07053930

Brief Summary

There is always a debate for choosing the best method for management of the third stage of labour (TSL) in the general practice for reducing the duration of TSL. Although intravenous oxytocin is more extensively used in general practice for managing TSL than intraumbilical, it still needs to be properly investigated among local populations and in local settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
Last Updated

July 8, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 27, 2025

Last Update Submit

June 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Duration of the third stage labour

    The duration of the third stage labour was measured from the completed delivery of the newborn until the completed delivery of the placenta.

    30 minutes

Study Arms (2)

Intraumbilical oxytocin group

EXPERIMENTAL

Patients were given 10 U of intraumbilical oxytocin, diluted in 10 mL of normal saline.

Drug: Intraumbilical oxytocin

Intravenous oxytocin group

EXPERIMENTAL

Patients received 20 U of intravenous oxytocin diluted in 500 mL of normal saline.

Drug: Intravenous oxytocin

Interventions

Patients were given 10 U of intraumbilical oxytocin, diluted in 10 mL of normal saline.

Intraumbilical oxytocin group

Patients received 20 U of intravenous oxytocin diluted in 500 mL of normal saline.

Intravenous oxytocin group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Females aged 18-40 years
  • With spontaneous vaginal delivery
  • Singleton pregnancy
  • Gestational age \>37 weeks
  • Parity l-5
  • Any gravidity

You may not qualify if:

  • Females with intrauterine fetal death
  • Malpresentation
  • Multiple pregnancy
  • Polyhydramnios
  • Premature rupture of membranes
  • Medical disorders and hypertensive disorders of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sadiq Abbasi Hospital

Bahawalpur, Punjab Province, 63100, Pakistan

Location

Study Officials

  • Anam Javed

    Sadiq Abbasi Hospital, Bahawalpur, Pakistan

    PRINCIPAL INVESTIGATOR
  • Komal Iqbal

    Sadiq Abbasi Hospital, Bahawalpur, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 8, 2025

Study Start

October 1, 2024

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

July 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations