Drotaverine to Shorten the Length of Labor
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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 |
- Duration of the active first stage of labor [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- 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 |
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| Egypt | |
| 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 |
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 |
ClinicalTrials.gov processed this record on May 21, 2013