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Drotaverine to Shorten the Length of Labor

This study has been completed.
Information provided by (Responsible Party):
Mohammed Abd El Hameed Abd El Lateef, Ain Shams Maternity Hospital Identifier:
First received: July 9, 2012
Last updated: January 17, 2013
Last verified: January 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 Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Use of Antispasmodic Drotaverine to Shorten the Length of Labor in Nulliparous Women

Resource links provided by NLM:

Further study details as provided by Mohammed Abd El Hameed Abd El Lateef, Ain Shams Maternity Hospital:

Primary Outcome Measures:
  • Duration of the active first stage of labor [ Time Frame: 12 hours ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 352
Study Start Date: May 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Drotaverine
Women who will receive 40 mg Drotaverine hydrochloride (Do-Spa) IV injection.
Drug: Drotaverine
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.
Drug: Placebo
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)

  Show Detailed Description


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women aged between 18 and less than 35 years.
  • Primigravidae.
  • Singleton pregnancy.
  • Term gestation i.e., 37-42 weeks.
  • Sure, reliable dates documented by ultrasound in the 1st half of pregnancy.
  • Vertex presentation with occipito anterior position
  • Regular uterine contractions at a rate of at least 3 to 4 contractions every 10 minutes, each contraction lasting for at least 40 seconds.
  • Cervical dilatation of 3-5 cm.
  • With or without rupture of membranes
  • No evidence of maternal or fetal distress.

Exclusion Criteria:

  • Cephalo-pelvic disproportion.
  • Cervical surgery in the past or history of cervical injury.
  • Patients on antihypertensive therapy.
  • Known hypersensitivity to Drotaverine hydrochloride.
  • If any other spasmolytic agent had been used within 48 hours.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01639027

Labor at the delivery unit of Ain Shams Maternity Hospital
Abbasiya, Cairo, Egypt, 11566
Sponsors and Collaborators
Ain Shams Maternity Hospital
Study Director: Mostafa Ibrahem, MD Ain Shams University
Study Chair: Mohamed Ellaithy, MD Ain Shams University
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mohammed Abd El Hameed Abd El Lateef, Investigator, Obstetrics and Gynaecology, Ain Shams Maternity Hospital Identifier: NCT01639027     History of Changes
Other Study ID Numbers: Drotaverine in labor
Study First Received: July 9, 2012
Last Updated: January 17, 2013

Additional relevant MeSH terms:
Asphyxia Neonatorum
Labor Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Autonomic Agents
Vasodilator Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents processed this record on September 21, 2017