To study the role of Inj.Valethamate bromide to shorten the duration of labour in low risk pregnant women in a tertiary care center in South India .

: A randomized controlled trial to determine the role of Inj. Valethamate bromide in reduction of duration of labor in low risk pregnant women in a tertiary care center in South India . - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058383

Enrollment

600

Registered

2023-10-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: O630- Prolonged first stage (of labor)

Interventions

Intervention1: Inj.Valethamate bromide: 16 mg Inj.Valethamate bromide in 50 ml normal saline intravenous for 10 min Control Intervention1: Placebo: Normal saline 50 ml intravenous for 10 min

Eligibility

Inclusion criteria

Inclusion criteria: 1. Low risk pregnant women, primigravida and multigravida at term (more than and equal to 37 weeks till 40 weeks and 6 days of gestation) 2. Singleton pregnancy, cephalic presentation 3. Cervical dilation of 2-4 cms on initial examination with or without rupture of membranes. 4.Spontaneous and induced labor 5.Gestational diabetes on medical nutritional therapy with well controlled sugars and average size baby

Exclusion criteria

Exclusion criteria: 1.High risk pregnancy which includes gestational hypertension and pre eclampsia and eclampsia,gestational diabetes on insulin with uncontrolled sugars ,multiple pregnancy, heart disease complicating pregnancy, previous LSCS or previous uterine scar, previous bad obstetric history. 2. Preterm labor 3. Patient with false labor 4. Non vertex presentation 5.Para 4 or more 6.Non reassuring CTG.

Design outcomes

Primary

Measure	Time frame
Intervention to delivery intervalTimepoint: September 2023 to September 2024	—

Secondary

Measure	Time frame
To study the association of the following on administration of the study drug 1.Maternal complications: tachycardia, flushing,dry mouth,mydriasis-related photophobia hyperstimulation, postpartum haemorrhage,incidence of meconium stained liquor 2.Total dose of oxytocin required 3. Number of caesarean sections & instrumental deliveries 4.Fetal complications: NRFS,NICU admissions,low APGAR scores Timepoint: September 2023 to September 2024	—

Measure

Time frame

To study the association of the following on administration of the study drug 1.Maternal complications: tachycardia, flushing,dry mouth,mydriasis-related photophobia hyperstimulation, postpartum haemorrhage,incidence of meconium stained liquor 2.Total dose of oxytocin required 3. Number of caesarean sections & instrumental deliveries 4.Fetal complications: NRFS,NICU admissions,low APGAR scores Timepoint: September 2023 to September 2024

—

Countries

India

Contacts

Public ContactDr V Annie Prasanthi

Christian Medical College,Vellore

drannieprasanthi@gmail.com9843676327

Outcome results

None listed

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