NCT02362139

Brief Summary

In the investigators institution, there is a wide use of Papaverine in delivery room, but this use is optional, and is left to the discretion of the physician. The aim of the investigators study is to prospectively evaluate the influence of Papaverine administration in the latent phase of labor, on the duration of labor.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

2 years

First QC Date

February 8, 2015

Last Update Submit

February 11, 2015

Conditions

Duration of Labor.

Outcome Measures

Primary Outcomes (1)

  • The duration of time between Papaverine administration and delivery.

    24 month

Secondary Outcomes (3)

  • Duration of second and third stages of labor

    24 month

  • Cervical dilatation rate (cm\Hr)

    24 month

  • Papaverine adverse outcome

    24 month

Study Arms (2)

The study group

EXPERIMENTAL

200 pregnant women, 18-45 years old, 37-41 weeks of gestation, in spontaneous labor, which were treated with 80 mg of Intra-muscular (IM) Papverine during the latent phase of labor (cervical dilatation\<4cm).

Drug: The study group

The control group

NO INTERVENTION

200 pregnant women, 18-45 years old, 37-41 weeks of gestation, in spontaneous labor, which were not treated with IM Papverine

Interventions

The study groupDRUG

200 pregnant women, 18-45 years old, 37-41 weeks of gestation, in spontaneous labor, which were treated with 80 mg of Intra-muscular (IM) Papverine during the latent phase of labor (cervical dilatation\<4cm).

Also known as: Papverine
The study group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancy.
  • weeks of gestation.
  • Women who enter delivery room in spontaneous labor during the latent phase of labor (cervical dilatation \<4cm).
  • Maternal age between 18 and 45.

You may not qualify if:

  • Women who enter delivery room during the active phase of labor (cervical dilatation greater than 5 cm).
  • Women with previous cesarean section
  • Women with premature rupture of membranes (PROM)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Eran Ashwal, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eran Ashwal, MD

CONTACT

972-39377218rmc@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

February 8, 2015

First Posted

February 12, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

February 12, 2015

Record last verified: 2015-02