The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes

Study Overview
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Brief Summary
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The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes. The study compared 2 time periods. The first time period was between May 2011 until April 2014 when a prolonged second stage in nulliparous women was considered three hours with regional anesthesia or two hours if no such anesthesia was provided. Second stage arrest was defined in multiparous women after two hours with regional anesthesia or one hour without it. The second time period was between May 2014 until April 2017, allowed nulliparous and multiparous women to continue the second stage of labor an additional one hour before diagnosing second-stage arrest. Singleton deliveries at or beyond 37 weeks' gestation were initially considered for eligibility.

Detailed Description
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The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes. The study compared 2 time periods. The first time period was between May 2011 until April 2014 when a prolonged second stage in nulliparous women was considered three hours with regional anesthesia or two hours if no such anesthesia was provided. Second stage arrest was defined in multiparous women after two hours with regional anesthesia or one hour without it. The second time period was between May 2014 until April 2017, allowed nulliparous and multiparous women to continue the second stage of labor an additional one hour before diagnosing second-stage arrest. Singleton deliveries at or beyond 37 weeks' gestation were initially considered for eligibility. The rate of CS, operative vaginal deliveries, 3rd and 4th degree lacerations, postpartum hemorrhage, arterial cord PH below 7 and admissions to the neonatal intensive care unit (NICU).

Official Title
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The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Other: Protocol change


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Singleton deliveries at or beyond 37 weeks' gestation. Exclusion Criteria: Non-vertex presentation. Trial of labor after CS. High risk pregnancy (multiple gestation, preeclampsia, diabetes mellitus, intrauterine growth restriction). Known fetal anomalies and intrauterine fetal demise.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prolonged second stage of labor<br>Women with prolonged second stage of labor as specified before. | Other: Protocol change<br>* To examine the effect of prolonging the second stage of labor on the rate of cesarean delivery, maternal and neonatal outcomes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of primary CS. | The rate of primary CS in percentage of the total participants. | Between 2011 and 2017. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of operative vaginal delivery. | The rate of operative vaginal delivery in percentage of the total participants. | Between 2011 and 2017. | 
| Post-partum hemorrhage. | Post-partum hemorrhage as estimated in liters. | Between 2011 and 2017. | 
| The need for blood transfusion. | Number and type of blood products required post-partum and calculation of the number of patients that required blood products out of the total number of participants in percentage. | Between 2011 and 2017. | 
| Third-and fourth-degree laceration rate. | Third-and fourth-degree laceration rate of the total number of participants. | Between 2011 and 2017. | 
| Chorioamnionitis rate. | Chorioamnionitis rate in percentage of the total participants. | Between 2011 and 2017. | 
| Admission to the NICU. | Admission to the NICU in percentage of the total participants. | Between 2011 and 2017. |