Randomized controlled trial of prolonged second stage: extending the time limit vs usual guidelines.

نویسنده

  • Andrew P Jovanovski
چکیده

BACKGROUND Guidelines for management of the second stage have been proposed since the 1800s and were created largely by expert opinion. Current retrospective data are mixed regarding differences in maternal and neonatal outcomes with a prolonged second stage. There are no randomized controlled trials that have evaluated whether extending the second stage of labor beyond current American College of Obstetricians and Gynecologists recommendations is beneficial. OBJECTIVE The purpose of this study was to evaluate whether extending the length of labor in nulliparous women with prolonged second stage affects the incidence of cesarean delivery and maternal and neonatal outcomes. STUDY DESIGN We conducted a randomized controlled trial of nulliparous women with singleton gestations at 36 0/7 to 41 6/7 weeks gestation who reached the American College of Obstetricians and Gynecologists definition of prolonged second stage of labor, which is 3 hours with epidural anesthesia or 2 hours without epidural anesthesia. Women were assigned randomly to extended labor for at least 1 additional hour, or to usual labor, which was defined as expedited delivery via cesarean or operative vaginal delivery. The exclusion criteria were intrauterine fetal death, planned cesarean delivery, age <18 years, and suspected major fetal anomaly. Primary outcome was incidence of cesarean delivery. Maternal and neonatal outcomes were compared secondarily. Statistical analysis was done by intention-to-treat. RESULTS Seventy-eight nulliparous women were assigned randomly. All of the women had epidural anesthesia. Maternal demographics were not significantly different. The incidence of cesarean delivery was 19.5% (n = 8/41 deliveries) in the extended labor group and 43.2% (n = 16/37 deliveries) in the usual labor group (relative risk, 0.45; 95% confidence interval, 0.22-0.93). The number needed-to-treat to prevent 1 cesarean delivery was 4.2. There were no statistically significant differences in maternal or neonatal morbidity outcomes. CONCLUSION Extending the length of labor in nulliparous women with singleton gestations, epidural anesthesia, and prolonged second stage decreased the incidence of cesarean delivery by slightly more than one-half, compared with usual guidelines. Maternal or neonatal morbidity were not statistically different between the groups; however, our study was underpowered to detect small, but potentially clinical important, differences.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Important considerations in calculating and reporting of sample size in randomized controlled trials

Background: The calculation of the sample size is one of the most important steps in designing a randomized controlled trial. The purpose of this study is drawing the attention of researchers to the importance of calculating and reporting the sample size in randomized controlled trials. &nbsp;&nbsp; Methods: We reviewed related literature and guidelines and discussed some important issues in s...

متن کامل

Comparing the Effect of Dexamethasone before and after Tracheal Intubation on Sore Throat after Tympanoplasty Surgery: A Randomized Controlled trial

Introduction: Presence of a sore throat after surgery is a common side effect of general anesthesia with intratracheal intubation and can cause discomfort for the patient and prolong the recovery process. In this study we compared the effect of dexamethasone before and after intubation on the incidence of sore throat after tympanoplasty surgery.   Materials and Methods: In a double-blind, rando...

متن کامل

Effect of Statin Treatment on COVID-19 Patients’ Outcomes: A Randomized Double-blind Controlled Clinical Trial

Background: Statins may be protective against viral infection and have been suggested for the treatment of coronavirus disease 2019 (COVID-19).  Objective: In this study, we aimed to evaluate the effect of atorvastatin on COVID-19 patients. Methods: Our study is a randomized double-blind controlled clinical trial that constitutes a population of COVID-19 patients admitted to Bu-Ali Sina Hospi...

متن کامل

Predictors of Missed Research Appointments in a Randomized Placebo-Controlled Trial

Background:  The primary aim of this study was to determine predictors of missed research appointments in a prospective  andomized placebo injection-controlled trial with evaluations 1 to 3 and 5 to 8 months after enrollment.   Methods:  This study represents a secondary use of data from 104 patients that were enrolled in a prospective randomized  ontrolled trial of dexamethasone versus lidocai...

متن کامل

Maintenance Therapy by Vaginal Progesterone after Threatened Idiopathic Preterm Labor: A Randomized Placebo-Controlled Double-blind Trial

Background Patients with arrested preterm labor (PTL) are at increased risk for recurrence of preterm birth (PTB). Maintenance tocolysis after arrest of acute PTL is of questionable value. The objective of this study was to evaluate the efficacy of 200 mg vaginal progesterone in order to prevent PTB in women with episodes of threatened PTL. MaterialsAndMethods This is a randomized double blind ...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:
  • American journal of obstetrics and gynecology

دوره 214 3  شماره 

صفحات  -

تاریخ انتشار 2016