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Drotaverine to Shorten the Length of Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01639027
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : January 18, 2013
Information provided by (Responsible Party):
Mohammed Abd El Hameed Abd El Lateef, Ain Shams Maternity Hospital

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?

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
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
Study Start Date : May 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

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

Secondary Outcome Measures :
  1. Rate of cervical dilation (cm/h) [ Time Frame: 12 hours ]
  2. Effect on pain by using visual analogue scale [ Time Frame: 12 hours ]
  3. Mode of delivery [ Time Frame: 12 hours ]
  4. APGAR score less than 7 at 1 and 5 minutes [ Time Frame: 12 hours ]

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01639027

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Labor at the delivery unit of Ain Shams Maternity Hospital
Abbasiya, Cairo, Egypt, 11566
Sponsors and Collaborators
Ain Shams Maternity Hospital
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Study Director: Mostafa Ibrahem, MD Ain Shams University
Study Chair: Mohamed Ellaithy, MD Ain Shams University
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mohammed Abd El Hameed Abd El Lateef, Investigator, Obstetrics and Gynaecology, Ain Shams Maternity Hospital Identifier: NCT01639027    
Other Study ID Numbers: Drotaverine in labor
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: January 18, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Labor Pain
Neurologic Manifestations
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Autonomic Agents
Vasodilator Agents