The Effect Of Kristeller Maneuver On Maternal And Neonatal Outcome

September 10, 2013 updated by: Gökhan Açmaz, Kayseri Education and Research Hospital

A Prospective, Randomized, Controlled Trial

The use of fundal pressure in management of the second stage of labor is controversial. The aim of this study is both to evaluate the effectiveness of fundal pressure in shortening the second stage of labor and to examine the related neonatal and maternal outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be randomly allocated to two groups by using a computer-generated random number chart: Kristeller maneuver intervention (study) group (n=140) and control group (n=140). Umbilical artery blood gas will obtained to assess the newborn's acid-base status. The umbilical artery levels of creatinine kinase, creatinine kinase with myocardial specific isoform, aspartate amino transferase, alanine amino transferase, lactate dehydrogenase and lactic acid will be measured. Length of episiotomy and length of vagina will be measured at 45 degrees from the midline. Each patient's vaginal laceration, cervical laceration, length of episiotomy and vagina before and after delivery and duration of the second stage of labor in minutes will be recorded. Neonatal information will include: infant birth weight, apgar scores, babies requiring pediatric help, and admission of neonatal intensive care units.

Study Type

Interventional

Enrollment (Actual)

285

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38039
        • Gökhan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnants who were administered for delivery and signed informed consent form were included into the study.

Exclusion Criteria:

  • Pregnant who required oxytocin augmentation, multiple gestations, pregnant with medical problems (such as asthma, thyroid, cardiac, liver, kidney disease, preeclampsia and diabetes), pregnant with previous caesarean and pregnant whose estimated fetal weight <2500gr or >4000gr were not included into the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: KRISTELLER
Uterine fundal pressure
Behavioral: KRISTELLER

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vaginal laceration, cervical laceration, length of episiotomy and vagina before and after delivery
Time Frame: up to 6 months
It is a composite outcome measure consisting of multiple measures.
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The umbilical artery levels of creatinine kinase, creatinine kinase with myocardial specific isoform, aspartate amino transferase, alanine amino transferase, lactate dehydrogenase and lactic acid were measured.
Time Frame: up to 6 months
It is a composite outcome measure consisting of multiple measures.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kayseri Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 2, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Estimate)

September 11, 2013

Last Update Submitted That Met QC Criteria

September 10, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KayseriERH (KayseriERH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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