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The Effect Of Kristeller Maneuver On Maternal And Neonatal Outcome

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ClinicalTrials.gov Identifier: NCT01939873
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : September 11, 2013
Sponsor:
Information provided by (Responsible Party):
Gökhan Açmaz, 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.

Condition or disease Intervention/treatment Phase
Secons Stage of Labor Behavioral: KRISTELLER Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
Official Title: A Prospective, Randomized, Controlled Trial
Study Start Date : September 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Experimental: KRISTELLER
Uterine fundal pressure
Behavioral: KRISTELLER
No Intervention: Control group



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939873


Locations
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Turkey
Gökhan
Kayseri, Turkey, 38039
Sponsors and Collaborators
Kayseri Education and Research Hospital

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Responsible Party: Gökhan Açmaz, Kayseri Education and Research Hospital
ClinicalTrials.gov Identifier: NCT01939873     History of Changes
Other Study ID Numbers: KayseriERH
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013

Keywords provided by Gökhan Açmaz, Kayseri Education and Research Hospital:
Kristeller maneuver; Second stage of labor;
Perineal laceration; Obstetrical outcome;
Neonatal outcome