Drotaverine to Shorten the Length of Labor
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|ClinicalTrials.gov Identifier: NCT01639027|
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : January 18, 2013
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?
|Condition or disease||Intervention/treatment||Phase|
|Prolonged First Stage of Labor Failure of Cervical Dilation as Antepartum Condition Labor Pain Mild Birth Asphyxia, APGAR 4-7||Drug: Drotaverine Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||352 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Use of Antispasmodic Drotaverine to Shorten the Length of Labor in Nulliparous Women|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||January 2013|
Active Comparator: Drotaverine
Women who will receive 40 mg Drotaverine hydrochloride (Do-Spa) IV injection.
40 mg Drotaverine hydrochloride (Do-Spa) IV injection at the start of the study and repeated every 2 hours up to a maximum 3 injections.
Other Name: Do Spa
Placebo Comparator: Placebo
Women who will receive 2ml of normal physiological saline (0.9% sodium chloride) I.V.
Women who will receive 2ml of normal physiological saline (0.9% sodium chloride) I.V at the start of the active phase of labor.
Other Name: Normal physiological saline (0.9% sodium chloride)
- Duration of the active first stage of labor [ Time Frame: 12 hours ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639027
|Labor at the delivery unit of Ain Shams Maternity Hospital|
|Abbasiya, Cairo, Egypt, 11566|
|Study Director:||Mostafa Ibrahem, MD||Ain Shams University|
|Study Chair:||Mohamed Ellaithy, MD||Ain Shams University|