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The Effect Of Kristeller Maneuver On Maternal And Neonatal Outcome

NCT ID: NCT01939873

Last Updated: 2013-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Secons Stage of Labor

Keywords

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Kristeller maneuver; Second stage of labor; Perineal laceration; Obstetrical outcome; Neonatal outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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KRISTELLER

Uterine fundal pressure

Group Type EXPERIMENTAL

KRISTELLER

Intervention Type BEHAVIORAL

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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KRISTELLER

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kayseri Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gökhan Açmaz

Kayseri Education and Research Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gökhan

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KayseriERH

Identifier Type: -

Identifier Source: org_study_id