Drotaverine to Shorten the Length of Labor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohammed Abd El Hameed Abd El Lateef, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier:
NCT01639027
First received: July 9, 2012
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Ain Shams Maternity Hospital:

Primary Outcome Measures:
  • Duration of the active first stage of labor [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of cervical dilation (cm/h) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Effect on pain by using visual analogue scale [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Mode of delivery [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • APGAR score less than 7 at 1 and 5 minutes [ Time Frame: 12 hours ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01639027

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

Additional Information:
No publications provided

Responsible Party: Mohammed Abd El Hameed Abd El Lateef, Investigator, Obstetrics and Gynaecology, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT01639027     History of Changes
Other Study ID Numbers: Drotaverine in labor
Study First Received: July 9, 2012
Last Updated: January 17, 2013
Health Authority: Egypt: Institutional Review Board

Additional relevant MeSH terms:
Asphyxia Neonatorum
Asphyxia
Labor Pain
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Drotaverin
Papaverine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Parasympatholytics
Autonomic Agents
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 26, 2014