Randomized Control Trial of Second Stage of Labor

Labor Complications Clinical Trial

Official title:

Randomized Control Trial of Usual Labor Versus Extended Second Stage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101515
• Other study ID #: 13D.590
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: July 2015

Study information

• Verified date: January 2018
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Complications
• Obstetric Labor Complications

Intervention

Other:
• Length of Second Stage
The experimental group will have one additional hour in the second stage of labor

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hosptial	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Operative Vaginal Delivery		at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
Other	Spontaneous Vaginal Delivery		at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
Other	Endometritis	Clinical diagnosis of postpartum endometritis of the mother	at time of delivery until maternal discharge, usually < 5 days
Other	Transfusion	Any transfusion of packed red blood cells to the mother or any other blood products given.	at time of delivery until maternal discharge, usually < 5 days
Other	3rd/4th Degree Laceration	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.	at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
Other	Number of Participants With Shoulder Dystocia		at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
Other	Neonatal Intensive Care Unit Admission (Neonates)	One neonate was analyzed per mother	Birth until neonatal discharge
Other	Chorioamnionitis	Clinical diagnosis of Chorioamnionitis of the mother	at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
Other	Neonatal Sepsis (Neonate)	Diagnosed by neonatology, one neonate was analyzed per mother	until neonatal discharge, usually < 5 days
Other	Birth Weight (Neonate)	One neonate was analyzed per mother	at time of delivery
Other	Neonatal Seizures (Neonate)	Diagnosed by neonatology, one neonate was analyzed per mother	until discharge, usually < 5 days
Other	Neonatal Length of Stay (Neonate)	one neonate was analyzed per mother	until neonatal discharge, usually < 5 days
Other	Neonatal Mortality (Neonate)	one neonate was analyzed per mother	early neonatal mortality (within 7 days of birth).
Other	Continuous Positive Airway Pressure or Greater (Neonate) Such as Intubation, Mechanical Ventilation, Nasal Intermittent Positive Pressure Ventilation, High-frequency Oscillatory Ventilation	Number of neonates who required continuous positive airway pressure or greater.	Until neonatal discharge, usually < 5 days
Primary	Number of Patients Delivered by Cesarean	Number of patients delivered by cesarean delivery for the extended labor group	At time of delivery, up to 4 hours of the second stage for "Extended group" and 3 hours for "Usual group"
Secondary	Number of Newborns With Umbilical Artery pH < 7.10	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.	at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"
Secondary	Postpartum Hemorrhage	Number of participants who experienced a postpartum hemorrhage	at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual"