Clinical Trial: Drotaverine to Shorten the Length of Labor
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Use of Antispasmodic Drotaverine to Shorten the Length of Labor in Nulliparous Women
Brief Summary:
Reducing the length of labor is a highly desirable goal of intrapartum care, both from a perspective of maternal and fetal well-being, and for the providers of the birth services. Avoiding along, protracted labor entails shorter exposure to pain, anxiety and stress and would thus translate into a major improvement in maternal satisfaction with the childbirth experience.
Based on the premise that shortening the length of labor is beneficial, interventions aimed at accelerating the progression of labor have been introduced routinely as part of standard labor management and care throughout the 20th century. Certain labor accelerative procedures, such as amniotomy, became common practice and have been put to the acid test of randomized control trials to evaluate their efficacy. Use of anticholinergics/antispasmodics as a method of augmenting labor was first described in 1937 by Hirsch, who reported a decrease in labor length by two to four hours following Intrapartum administration of an atropine-like drug (Syntropan®)mainly among older nulliparas.
Drotaverine, an isoquinolone derivative is a superior smooth muscle relaxant which acts specifically on spastic sites and corrects the cAMP and calcium balance relieving smooth muscle spasm.
This inhibitory action is detected only in lower uterine segment during labor since muscle fibers in upper uterine segment are strongly affected by contractile effect of oxytocin. Use of drotaverine during pregnancy is free of any teratogenic and embryotoxic effects.
The Research question is: Does the use of antispasmodic Drotaverine shorten the duration of active first stage of labor in nulliparous women as compared to placebo?
Detailed Summary:
Research question:
Does the use of antispasmodic Drotaverine shorten the duration of active first stage of labor in nulliparous women as compared to placebo?
Research hypothesis: the population means of the Drotaverine and placebo groups are equal regarding the duration of the first stage of labor.
Objectives:
The purpose of this study was to determine the effectiveness of Drotaverine for reducing the duration of labor for the context of contemporary practice, among nulliparous women managed according to a standard intrapartum protocol.
Study setting:
Patients will be recruited from women admitted in labor at the delivery unit of Ain Shams Maternity Hospital.
Study design:
This study is a phase II to III, intervention study- Randomized Controlled double blind study.
Procedure:
Every patient will be subjected to:
- Complete history to exclude allergy to Drotaverine Hydrochloride and any contraindication for normal vaginal delivery.
- General examination of the patients including (pulse, blood pressure, temperature).
- Obstetric Abdominal examination including lie, presentation,station; fetal heart rate, uterine contraction, amount of liquor and to exclude multiple pregnancies.
- Vaginal examination under aseptic conditions to assess cervical dilation, effa
Sponsor: Ain Shams Maternity Hospital
Current Primary Outcome: Duration of the active first stage of labor [ Time Frame: 12 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Rate of cervical dilation (cm/h) [ Time Frame: 12 hours ]
- Effect on pain by using visual analogue scale [ Time Frame: 12 hours ]
- Mode of delivery [ Time Frame: 12 hours ]
- APGAR score less than 7 at 1 and 5 minutes [ Time Frame: 12 hours ]
Original Secondary Outcome: Same as current
Information By: Ain Shams Maternity Hospital
Dates:
Date Received: July 9, 2012
Date Started: May 2012
Date Completion:
Last Updated: January 17, 2013
Last Verified: January 2013
