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The Effect Of Kristeller Maneuver On Maternal And Neonatal Outcome

A Prospective, Randomized, Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01939873
Enrollment
285
Registered
2013-09-11
Start date
2012-09-30
Completion date
2013-08-31
Last updated
2013-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secons Stage of Labor

Keywords

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

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.

Interventions

BEHAVIORALKRISTELLER

Sponsors

Kayseri Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
vaginal laceration, cervical laceration, length of episiotomy and vagina before and after deliveryup to 6 monthsIt is a composite outcome measure consisting of multiple measures.

Secondary

MeasureTime frameDescription
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 monthsIt is a composite outcome measure consisting of multiple measures.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026