Assessment of Maternal and Perinatal Morbidity and Mortality in Vaginal and Cesarean Delivery

Assessment of Maternal and Perinatal Morbidity and Mortality in Vaginal and Cesarean Delivery Among a Sample of Women Delivering at Ain Shams University Maternity Hospital

This study will be done at Ain Shams university maternity hospital to identify the significant risk of maternal intensive care unit admission, need for advanced surgery, postpartum hemorrhage, need for blood transfusion, febrile morbidity, neonatal intensive care unit admission (NICU), need for neonatal intubation and low APGAR scoring in both vaginal and cesarean section .and this will lead us to know if cesarean section rates in our unit is a safe alternative to vaginal delivery and which of both maneuvers will introduce fewer hazards to mother and fetus.

Study Overview

• Status: Unknown
• Conditions: Delivery ,Complications,Maternal; Delivery,Complication,Fetal
• Intervention / Treatment: Procedure: cesarean delivery

Detailed Description

• Type of Study: a cross-sectional study
• Study Setting: Ain Shams maternity hospital
• Study Period: 6 months
• Study Population: in this prospective study, all women who deliver vaginally and by cesarean section at Ain Shams maternity hospital will be included.
• Sampling Method: All of the pregnant women who will deliver vaginally and all of pregnant women who will deliver by cesarean sections in the labor delivery room at Ain Shams University Maternity Hospital on a fixed day and by a fixed team over a period of 6 months
• Sample Size: all pregnant women who will deliver at Ain Shams maternity hospital.

• Inclusion criteria :

  • All of the patients who will deliver vaginally
  • All of the patients who will deliver by cesarean sections.
• Exclusion criteria: no exclusion criteria, all women who will attend for delivery will be included.
• Ethical Considerations: the study objectives will be briefly and clearly described to all participants and an oral consent will be obtained from all patients.
• Study Procedures :

In all selected cases the following will be recorded:

Parameters of maternal morbidity:

1. ICU admission due to the complication of delivery.
2. Need for advanced surgery (int. iliac ligation -hysterectomy -or due to the injury of pelvic organs).
3. Febrile morbidity temp >38C on two or more occasion within 48h of delivery.
4. Postpartum hemorrhage (blood loss 500cc in VD and 1liter in C\S).
5. Wound infection.
6. Late complications e.g. (D.V.T-puerperal sepsis and hematoma).
7. Need for blood transfusion post labor
8. Maternal mortality.

Parameters of fetal morbidity:

1. Intracranial hemorrhage as compilations of delivery.
2. Neonatal ICU admission as compilations of delivery
3. Fracture (Femur, ribs, and humorous)
4. Meconium aspiration.
5. Erb's palsy.
6. APGARscore1-5.

7. Need for intubation during resuscitation.

   • Statistical analysis The patient will be subdivided into 4 groups, normal VD, instrumental VD, emergency C\S, and elective C\S The data has been collected in analytical sheet tabulated and statistical analysis using the following tests

1- T-test. 2- Chi-square test. 3- Fisher exact test

Statistical package :

data analysis will be performed by SPSS 16.0 using descriptive statistics tools, including mean, standard deviation and figures.A t-test will be used to compare mean values of the two groups .P-values, smaller than 0.05, were considered statistically significant.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Mohamed M Samy, MD; Phone Number: 01001947488; Email: Mohammedsamy8132@gmail.com
• Study Contact Backup: Name: Ahmed N Shaker; Phone Number: 01098670624; Email: dr_nagy.ahmed@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • Recruiting
    • Ain Shams Maternity Hospital
    • Contact: abd el fatah soaod, proffesor; Phone Number: +226834576; Email: viced.research@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

all women who delivered vaginally and by cesarean section at Ain Shams maternity hospital will be included.

Description

Inclusion Criteria:

• All of the patients who will deliver vaginally
• All of the patients who will deliver by cesarean sections.

Exclusion Criteria:

• no exclusion criteria, all women who will attend for delivery will be included.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normal vaginal delivery
assisted vaginal delivery
elective cesarean delivery	Procedure: cesarean delivery; women delivered by cesarean section
emergency cesarean delivery	Procedure: cesarean delivery; women delivered by cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
labor and delivery outcome	document maternal and perinatal morbidity	24 hours

Collaborators and Investigators

• Sponsor: Alzahraa Ismail Ragheb Goda
• Investigators: Principal Investigator: Tamer F Borg, professor, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 13, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: zahra2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No