Drotaverine to Shorten the Length of Labor

NCT01639027 | Completed Phase 2 DMC

• 1 other identifier: Drotaverine in labor
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

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?

Conditions

Prolonged First Stage of Labor; Failure of Cervical Dilation as Antepartum Condition; Labor Pain; Mild Birth Asphyxia, APGAR 4-7

Outcome Measures

Primary Outcomes (1)

• Duration of the active first stage of labor

  12 hours

Secondary Outcomes (4)

• Rate of cervical dilation (cm/h)

  12 hours

• Effect on pain by using visual analogue scale

  12 hours

• Mode of delivery

  12 hours

• APGAR score less than 7 at 1 and 5 minutes

  12 hours

Study Arms (2)

Drotaverine

ACTIVE COMPARATOR

Women who will receive 40 mg Drotaverine hydrochloride (Do-Spa) IV injection.

Drug: Drotaverine

Placebo

PLACEBO COMPARATOR

Women who will receive 2ml of normal physiological saline (0.9% sodium chloride) I.V.

Drug: Placebo

Interventions

Drotaverine DRUG

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.

Also known as: Do Spa

Drotaverine

Placebo DRUG

Women who will receive 2ml of normal physiological saline (0.9% sodium chloride) I.V at the start of the active phase of labor.

Also known as: Normal physiological saline (0.9% sodium chloride)

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Labor at the delivery unit of Ain Shams Maternity Hospital

Al ‘Abbāsīyah, Cairo Governorate, 11566, Egypt

Location

Related Publications (2)

• Ibrahim MI, Ellaithy MI, Hussein AM, Nematallah MM, Allam HA, Abdelhamid AS, Harara RM, Riad AA, Rafaat TA. Measurement of maternal serum amyloid A as a novel marker of preterm birth. J Matern Fetal Neonatal Med. 2021 Aug;34(15):2467-2472. doi: 10.1080/14767058.2019.1668370. Epub 2019 Sep 25.

  PMID: 31522581 DERIVED

• Ibrahim MI, Alzeeniny HA, Ellaithy MI, Salama AH, Abdellatif MA. Drotaverine to improve progression of labor among nulliparous women. Int J Gynaecol Obstet. 2014 Feb;124(2):112-7. doi: 10.1016/j.ijgo.2013.08.013. Epub 2013 Nov 7.

  PMID: 24299975 DERIVED

Related Links

• Ain Shams University

MeSH Terms

Conditions

Labor Pain

Interventions

drotaverin; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mostafa Ibrahem, MD

  Ain Shams University

  STUDY DIRECTOR

• Mohamed Ellaithy, MD

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, Obstetrics and Gynaecology

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: July 12, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: January 18, 2013

Record last verified: 2013-01

Locations

EG (1)