A clinical trial to study the effect of nitroglycerine patch in improving the fluid in the womb of mothers with reduced fluid in the womb.

Effect of transdermal nitroglycerine on liquor amount in oligohydramnios. A randomized placebo controlled trial

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000251

Enrollment

200

Registered

2008-12-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Nitroglycerine 25mg patch: Nitroglycerine 25mg patch for every 24 hours max 10 days dose increased to maximum of two patchs if no improvement in liquor amount Control Intervention1: pla

Eligibility

Inclusion criteria

Inclusion criteria: All pregnant women in the period of gestation between 24 - 40 weeks with amniotic fluid index (AFI) less than 8.

Exclusion criteria

Exclusion criteria: 1. Prelabour rupture of membranes 2. Lethal anomalies in fetus 3. Anomalies known to cause oligohydramnios. 4. Multiple pregnancies

Design outcomes

Primary

Measure	Time frame
Increase in amniotic fluid index of more than 8.Timepoint: till delivery	—

Secondary

Measure	Time frame
Number of patches required to increase the AFI treatment delivery interval Route of delivery Increase in AFI among high risk or low risk pregnancies Intrapartum non reassuring cardiotocograph and meconium staining of liquor Fetal outcome: APGAR and NICU admissions Timepoint: untill delivery	—

Countries

India

Contacts

Public ContactDr Sanjay Kuamr KR

manjunath.ap@manipal.edu09845913140

Outcome results