The Effect Of Kristeller Maneuver On Maternal And Neonatal Outcome

Not Applicable

Completed

• Conditions: Secons Stage of Labor
• Interventions: Behavioral: KRISTELLER

• Registration Number: NCT01939873
• Lead Sponsor: Kayseri Education and Research Hospital

Brief Summary

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

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 Timeline

• Study Start: 2012-09
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-09
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-10
• Last Update Submitted: 2013-09-10
• Study First Posted: 2013-09-11
• Last Update Posted: 2013-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 285

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KRISTELLER	KRISTELLER	Uterine fundal pressure

Primary Outcome Measures

Name	Time	Method
vaginal laceration, cervical laceration, length of episiotomy and vagina before and after delivery	up to 6 months	It is a composite outcome measure consisting of multiple measures.

Secondary Outcome Measures

Name	Time	Method
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.	up to 6 months	It is a composite outcome measure consisting of multiple measures.

Trial Locations

Locations (1)

Gökhan; 🇹🇷 Kayseri, Turkey