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العنوان
Propranolol and Oxytocin versus Oxytocin Alone for Induction of Labor :
المؤلف
Abd El-Rahman, Abd El-Rahman Mahmoud.
هيئة الاعداد
باحث / عبد الرحمن محمود عبد الرحمن
مشرف / مجـدى محمـد محمـود عبـد الجـواد
مشرف / رضــا مختــار كمــال
مشرف / مجـدى محمـد محمـود عبـد الجـواد
تاريخ النشر
2019.
عدد الصفحات
215 p. :
اللغة
الإنجليزية
الدرجة
ماجستير
التخصص
أمراض النساء والتوليد
تاريخ الإجازة
1/1/2019
مكان الإجازة
جامعة عين شمس - كلية الطب - التوليد وأمراض النساء
الفهرس
Only 14 pages are availabe for public view

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from 215

Abstract

Labor is a state of uterine contractions having adequate frequency, duration, and strength resulting in cervical effacement and dilatation .Prolonged labor could cause maternal and neonatal medical issues and these unfavorable labor clinical outcomes are elevated in prolonged gestations in comparison with term pregnancies. The cesarean section rates are rising during the last decades according to international research data. Prior research studies have revealed and displayed that labor induction could be correlated with raised Cesarean section rates. Numerous agents are implemented for labor induction and augmentation prostaglandins and oxytocin are the most widely used agents in practice . Intravaginal misoprostol appears to be more effective and less costy than dinoprostone which is administered intracervically or intravaginally, even though research based evidence in this issue show contradiction on the other hand researchers mention that dinoprostone appears to have a safer clinical profile due to lower frequency of uterine hyperstimulation and tachysystole .
In the current study the value of propranolol supplementary agent to oxytocin in women undergoing induction of labor to decrease of Cesarean section rate was evaluated . This is a Randomized Controlled Trial which was conducted in Ain Shams Maternity University Hospital in the period between May 2017 and May 2018 to compare the efficacy of propranolol and oxytocin vs. oxytocin alone for induction of labor at (38-41 week) gestational age that was done on 160 pregnant women which was divided into two groups each group contain 80 pregnant women.
RESEARCH METHODOLOGY
- After approval of the ethical committee, all participants in the study were given a written, informed consent, after explaining the details of the study to them .
Inclusion criteria:
- Age between 20 years and 35 years.
- Gestational age 38 - 41 weeks (according to a reliable last menstrual period and ultrasound evaluation at first trimester).
- Singleton viable pregnancy.
- Cephalic vertex presentation.
- Intact membranes.
- Bishop score > 5.
- Reassuring fetal well-being status.
- Maternal BMI btween (18-30kg/m2).
- Primigravida, or Previous one or previous two vaginal delivery.
Exclusion criteria
- Age more than 35 years or less than 20 years.
- Multiple pregnancy.
- Multigravida more than two vaginal delivery.
- Non-cephalic presentation.
- Presence of uterine contractions.
- History of uterine surgery eg. Cesarean section, myomectomy.
- Polyhydramnios.
- Pre-labor rupture of membranes.
- Non-reassuring fetal well-being status
- Contraindications to β-adrenergic agents, such as bronchial asthma systolic blood pressure less than 100 mmHg or pulse rate less than 60/min and more than 120/min
- History of any known cardiac disease
- Mother’s pulmonary or metabolic disorders
- Fetal distress
- Intrauterine fetal death.
- Estimated weight of the fetus more than 4 kg by ultrasound of cephalic presentation.
- Maternal obesity BMI >30kg/m2.
- Underwight patient BMI<18kg/m2.
Randomization:
Patients fulfilling the inclusion criteria were randomized to two groups.
Study Group:
This group was included 80 women undergoing induction of labor. In this group, the patients were received (two tablets of 10mg) 20 mg propranolol orally two hours before beginning induction, in addition to intravenous oxytocin. The tablets were repeated after 8 hours if no sufficient uterine contractions had been reached.
Control Group:
This group was included 80 women undergoing induction of labor. In this group, patients were received two a placebo tablets orally two hours before beginning induction, in addition to intravenous oxytocin. The tablets was be repeated after 8 hours if no sufficient uterine contractions had been reached.
All patients were subjected to the following:
- Proper history taking to obtain the following information:
- Clinical examination was done:
- General examination.
- Abdominal examination.
- Pelvic examination : Modified Bishop score
Investigations:
- Routine investigations were done, e.g. CBC, RBS, Urin, Blood group,Rh typing.
- Pelvi-abdominal U/S.
- Cardiotocography.
Continuos electronic fetal monitoringwas a must while oxytocin is used.
 Assessment of maternal-fetal status, as described below, - - Every 15 minutes during oxytocin administration (or at least every 30 minutes if oxytocin dosage is unchanged) with documentation in the patient medical record.
- Fetal heart rate: baseline rate, baseline variability, presence or absence of FHR accelerations and presence or absence of FHR decelerations.
- Uterine activity: contraction frequency, duration and intensity.
Data recruitment
- Age.
- Parity.
- BMI.
- Primary Bishop score.
- Gestational age.
- The number of previous deliveries.
- Time interval to achieve adequate uterine contractions after starting induction.
- Dose of oxytocin and/or propranolol required to achieve adequate uterine contractions.
- Duration of latent phase (interval between the beginnings of good contractions until cervical dilatations of 3–4 cm was be obtained).
- Duration of the active stage of labor.
- Mode of delivery.
- Apgar scores of minutes 1 and 5.
- Need for NICU admission.
- Neonatal weight and state (condition).
Ethics and legal data
 Good clinical practice:
 Patient information and informed consent:
 Protocol approval:
Before the beginning of the study and in accordance with the local regulation followed, the protocol was be declared for the Ethical and Research approval by the Council of the OB/GYN Department, Ain Shams University. Furthermore, the approval of the study protocol was be granted by Ethics Research Committee. Faculty of Medicine, Ain Shams University.
In the current research study recruited initially 214 cases 54 of the study subjects were excluded since they didn’t meet the exclusion criteria and 7 cases refused to join the studyleaving around 160 cases randomized into two research groups propranolol research group (80 study subjects )and placebo research group (80 study subjects )
As regards the basal demographic features of the investigated research groups there was no statistical significant difference between Probranolol and placebo research groups as regards age, BMI, parity, GA and Bishop Score.
The duration of latent phase was stastically significantly was shorter among propranolol research group than among placebo research group.
Although the duration of active phase of labor was statistically significantly shorter among propranolol research group than among placebo research group.
As regards the duration of second stage of labor was statistically significantly shorter among propranolol research group than among placebo research group.
Normal vaginal delivery in the current research study observations was statistically significantly more frequent among propranolol research group than among placebo research group.( 62 cases (77.5%) versus 49 cases (61.3%)
Furthermore the current research study findings the duration of third stage of labor was statistically non-significantly shorter among propranolol research group than among placebo research group
Finally there was no statistical significant difference between Probranolol and placebo research groups concerning birth weight, APGAR scores and NICU admission.