Randomized Control Trial of Second Stage of Labor

• ClinicalTrials.gov Identifier: NCT02101515
• Recruitment Status: Completed
• First Posted: April 2, 2014
• Results First Posted: October 26, 2018
• Last Update Posted: October 26, 2018
• Sponsor: Thomas Jefferson University
• Information provided by (Responsible Party): alexis gimovsky, Thomas Jefferson University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Labor Complications	Other: Length of Second Stage	Not Applicable

Detailed Description:

1. Consent at the time of admission or in the office
2. 2nd stage starts at full dilation
3. Randomization occurs at 2 hours without epidural or 3 hours with epidural, stratified by epidural status
4. Randomization scheme is according to a predetermined computer-generated block randomization scheme with block sizes of 6,8 and12 (random blocks).
5. 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.
6. 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.
7. Provider preference for cesarean delivery, operative vaginal delivery, continued pushing, with intention-to-treat analysis
8. Those that require cesarean delivery - usual perioperative management
9. Early termination criteria: emergency cesarean delivery, category 3 fetal heart tracing

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Control Trial of Usual Labor Versus Extended Second Stage
• Study Start Date: March 2014
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: July 2015

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Usual Labor; Immediate delivery after 3 hours with epidural or 2 hours without epidural	Other: Length of Second Stage; The experimental group will have one additional hour in the second stage of labor
Experimental: Extended; Immediate delivery after 4 hours with an epidural or 3 hours without an epidural Intervention: one additional hour for the second stage of labor Length of second stage in extended arm is 3 hours without epidural and 4 hours with epidural.	Other: Length of Second Stage; The experimental group will have one additional hour in the second stage of labor

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Pennsylvania

Thomas Jefferson University Hosptial

Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Thomas Jefferson University

Investigators

• Principal Investigator: Alexis Gimovsky, MD; Thomas Jefferson University
• Study Chair: Vincenzo Berghella, MD; Thomas Jefferson University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gimovsky AC, Phillips JM, Amero M, Levine J, Berghella V. Prolonged second stage effect on pelvic floor dysfunction: a follow up survey to a randomized controlled trial. J Matern Fetal Neonatal Med. 2021 Feb 14:1-6. doi: 10.1080/14767058.2021.1887122. [Epub ahead of print]

Gimovsky AC, Berghella V. Randomized controlled trial of prolonged second stage: extending the time limit vs usual guidelines. Am J Obstet Gynecol. 2016 Mar;214(3):361.e1-6. doi: 10.1016/j.ajog.2015.12.042.

• Responsible Party: alexis gimovsky, Fellow in Maternal Fetal Medicine, Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT02101515
• Other Study ID Numbers: 13D.590
• First Posted: April 2, 2014
• Results First Posted: October 26, 2018
• Last Update Posted: October 26, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Please contact Dr. Gimovsky at agimovsky@mfa.gwu.edu

Keywords provided by alexis gimovsky, Thomas Jefferson University:

randomized controlled trial; labor complications; cesarean section; second stage

Additional relevant MeSH terms:

Obstetric Labor Complications; Pregnancy Complications