The Effect Of Kristeller Maneuver On Maternal And Neonatal Outcome

Study Overview
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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.

Official Title
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A Prospective, Randomized, Controlled Trial

Conditions
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Secons Stage of Labor

Intervention / Treatment
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* Behavioral: KRISTELLER


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KRISTELLER<br>Uterine fundal pressure | Behavioral: KRISTELLER<br> <br> |
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kristeller maneuver; Second stage of labor;, Perineal laceration; Obstetrical outcome;, Neonatal outcome