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NCT Number: NCT02101515

Randomized Control Trial of Second Stage of Labor

The hypothesis of this study is that extending the second stage of labor beyond current American College of Obstetricians and Gynecologists suggestions can reduce the cesarean delivery rate. The cesarean delivery rate in the United States is around 30 percent. This is a number that continues to be increasing over the last few decades and will continue to climb. Each subsequent cesarean section puts the mother and baby at increased risk for postpartum hemorrhage, bowel and bladder injury, abnormal placentation, febrile morbidity and death. The most common reason for a cesarean delivery is a repeat cesarean delivery. One way to reduce this number is to prevent the first cesarean delivery. The aim of this study is evaluate if extending the second stage of labor affects the cesarean delivery rate and subsequent perinatal morbidity.

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Key information

Conditions

Labor Complications Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University Hosptial

Philadelphia, Pennsylvania, 19107, United States

About this study

  • Consent at the time of admission or in the office
  • 2nd stage starts at full dilation
  • Randomization occurs at 2 hours without epidural or 3 hours with epidural, stratified by epidural status
  • Randomization scheme is according to a predetermined computer-generated block randomization scheme with block sizes of 6,8 and12 (random blocks).
  • Sequentially numbered and sealed opaque envelopes prepared according to the randomization scheme and delivered to a secure container in labor and delivery suite to maintain concealed treatment allocation.
  • At the 3 hour mark, the next number envelope is pulled and opened by the physician/nurse to reveal the designated group. At this point the patient is considered randomized.
  • Provider preference for cesarean delivery, operative vaginal delivery, continued pushing, with intention-to-treat analysis
  • Those that require cesarean delivery - usual perioperative management
  • Early termination criteria: emergency cesarean delivery, category 3 fetal heart tracing

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Nulliparous women
  • singleton pregnancies
  • cephalic presentation
  • 36.0-41.6 weeks
  • age 18 and older

Exclusion criteria

  • Category 3 fetal heart tracing
  • major congenital anomalies
  • multiples
  • planned cesarean delivery
  • intrauterine fetal demise
  • Trial of labor after cesarean

Treatment and study plan

Length of Second Stage

Other

The experimental group will have one additional hour in the second stage of labor

Primary outcomes

  1. Number of Patients Delivered by Cesarean

    Time frame: At time of delivery, up to 4 hours of the second stage for "Extended group" and 3 hours for "Usual group"

    Number of patients delivered by cesarean delivery for the extended labor group

Secondary outcomes

  1. Number of Newborns With Umbilical Artery pH < 7.10

    Time frame: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"

    Umbilical artery pH is a marker for adverse neurological outcomes. Umbilical artery pH <7.10 has been proposed as a threshold for identifying fetuses who might develop pathologic fetal acidosis and fetal injury.

  2. Postpartum Hemorrhage

    Time frame: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"

    Number of participants who experienced a postpartum hemorrhage

Other outcomes

  1. Operative Vaginal Delivery

    Time frame: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"

  2. Spontaneous Vaginal Delivery

    Time frame: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"

  3. Endometritis

    Time frame: at time of delivery until maternal discharge, usually < 5 days

    Clinical diagnosis of postpartum endometritis of the mother

  4. Transfusion

    Time frame: at time of delivery until maternal discharge, usually < 5 days

    Any transfusion of packed red blood cells to the mother or any other blood products given.

  5. 3rd/4th Degree Laceration

    Time frame: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"

    3rd or 4th degree laceration or cervical laceration diagnosed at delivery

    Third degree lacerations extend through the fascia and musculature of the perineal body and involve some or all of the fibers of the external anal sphincter (EAS) and/or the internal anal sphincter.

    Third degree lacerations are subclassified as follows:

    • 3a: <50 percent of EAS thickness is torn
    • 3b: >50 percent of EAS thickness is torn
    • 3c: IAS is torn (in addition to complete rupture of the EAS)
    • Fourth degree lacerations involve the perineal structures, EAS, IAS, and the rectal mucosa.

  6. Number of Participants With Shoulder Dystocia

    Time frame: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"

  7. Neonatal Intensive Care Unit Admission (Neonates)

    Time frame: Birth until neonatal discharge

    One neonate was analyzed per mother

  8. Chorioamnionitis

    Time frame: at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"

    Clinical diagnosis of Chorioamnionitis of the mother

  9. Neonatal Sepsis (Neonate)

    Time frame: until neonatal discharge, usually < 5 days

    Diagnosed by neonatology, one neonate was analyzed per mother

  10. Birth Weight (Neonate)

    Time frame: at time of delivery

    One neonate was analyzed per mother

  11. Neonatal Seizures (Neonate)

    Time frame: until discharge, usually < 5 days

    Diagnosed by neonatology, one neonate was analyzed per mother

  12. Neonatal Length of Stay (Neonate)

    Time frame: until neonatal discharge, usually < 5 days

    one neonate was analyzed per mother

  13. Neonatal Mortality (Neonate)

    Time frame: early neonatal mortality (within 7 days of birth).

    one neonate was analyzed per mother

  14. Continuous Positive Airway Pressure or Greater (Neonate) Such as Intubation, Mechanical Ventilation, Nasal Intermittent Positive Pressure Ventilation, High-frequency Oscillatory Ventilation

    Time frame: Until neonatal discharge, usually < 5 days

    Number of neonates who required continuous positive airway pressure or greater.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

Randomized Control Trial of Usual Labor Versus Extended Second Stage

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 2, 2014
Registry last updated
Oct 26, 2018

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.

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