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COMPLETED
NCT07764406
NA

Effect Of Amniotomy In Early Labour On Duration Of Labour

Sponsor: Indus Hospital and Health Network

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if intentional rupturing of amniotic sac in early labour works to shorten the duration of labour. The main question it aims to answer is . Does the intentional rupture of amniotic sac in early labour lowers the duration of labour in primigravida at term as compared to expectant management. The researchers will compare mean duration of labor in intentional rupture of amniotic sac in early labour group to expectant management untill spontaneous rupture of amniotic sac in primigravida at term pregnancy. The participants will be randomly assigned to group A and B through lottery method using sealed opaque envelopes. In group A, amniotomy at 3cm will be done using aseptic measurements with the help of forcep. while in group B, membranes will be left intact. A partograph will be maintained in all patients throughout labor. Duration of each stage of labour will be monitored as per operational definition by the nurse not aware of treatment given. Fetal and maternal monitoring will be done half hourly till delivery of infant. Cesarean-section will be done in non-reactive CTG patients. In case of any of the adverse events related to intervention like placental abruption and cord prolapse \[that is less likely as the subjects are primigravida patients in which head is mostly already engaged before onset of labour\], and presence of meconium upon ARM that is not related to intervention individualized care will be provided like continuous electronic fetal monitoring and emergency caserean section will be kept in hand. If any adverse event occur related to intervention it will be reported to IRB within 24hours. All the patients will be kept under observation for 24 hours after delivery. All the data will be recorded on proforma

Official title: Effect Of Amniotomy In Early Labour On Duration Of Labour In Primigravida At Term Pregnancy: A Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-10-01

Completion Date

2026-04-28

Last Updated

2026-08-13

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Amniotomy (intentional rupture of amniotic sac during labour)

intentional rupture of amniotic sac during labour)

Locations (1)

Indus hospital and health network

Multan, Punjab Province, Pakistan