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Completed

NCT Number: NCT01939873

The Effect Of Kristeller Maneuver On Maternal And Neonatal Outcome

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gökhan

Kayseri, 38039, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KRISTELLER

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kayseri Education and Research Hospital

Other Gov

Registry information

Official study title

A Prospective, Randomized, Controlled Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 11, 2013
Registry last updated
Sep 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.