Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03666078 |
| Other study ID # |
zahra2018 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 15, 2018 |
| Est. completion date |
April 1, 2019 |
Study information
| Verified date |
January 2019 |
| Source |
Ain Shams Maternity Hospital |
| Contact |
Mohamed M Samy, MD |
| Phone |
01001947488 |
| Email |
Mohammedsamy8132[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
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.
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.
