Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03676621 |
| Other study ID # |
BMISO |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2018 |
| Est. completion date |
September 20, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the
uterine wall (hysterotomy). This definition does not include removal of the fetus from the
abdominal cavity in the case of uterine rupture or in the case of an abdominal pregnancy
Description:
patients and methods:
Type of Study
A prospective registered, double blinded, randomized controlled trial
Settings and localizations:
Operative list and emergency unit at Obstetrics and Gynecology Department, Women Health
Hospital, Assiut university, Egypt
Preliminary assessment of the patient
Obtain a detailed history from the patient
- Examination of the patient
1. General examination and evaluation of the vital signs ofthe patient ( pulse , blood
pressure , temperature and respiratory rate)
2. Obstetrical examination
Ultrasonograghic assessment (fetal viability , number of gestation, placental
location, amniotic fluid index)
Investigations ( complete blood count, Prothrombin time and concentration).
Inclusion criteria:
All legally adult pregnant women , above 18 years old ,at term with singleton
pregnancies booked for elective caesarean section accepting to participate in the
study.
Indications of cesarean section:
Repeated caesarean section(previous 2 cs or more).
previous one caesarean with oligohydramnios.
previous one caesarean with contracted pelvis.
previous one caesarean with malpresentation.
previous one caesarean section with decreased fetal movement.
primigravida with malpresentation.
primigravida with contracted pelvis.
Exclusion criteria:
Medical disorders involving the heart,liver,kidney or brain.
Diabetes mellitus and hypertension.
Patients requiring blood transfusion due to anemia.
Risk factors for uterine atony e.g. macrosomia , polyhydramnios ,multiple
pregnancies.
Placenta previa or placental abruption.
Previous major obstetric haemorrhage (>1000ml in previous Deliveries).
Known fibroid or adenomyosis.
Severe preeclampsia.
Uterine anomalies.
Women who received anticoagulant therapy.
Blood disorders (e.g. coagulopathies , thrombocytopenia).
Consent
Verbal and written consent were obtained from all eligible women .
The candidate women were divided into two groups. A computer generated random
numerical table was used by an independent statistician to prepare sealed opaque
envelopes containing a group assignment. Two groups of envelopes, corresponding to
two study groups, were given to a third party (a nurse), who was unaware of the
contents. The nurse distributed envelopes to patients, alternating between the
groups. Patientsassigned to group 1 received 5 IU oxytocin IV after delivery of the
fetus+ 2 tabs placepo . Patients assigned to group 2 received 400 in the buccal
space after anaesthesia + Iv saline infusion
Procedure:
Cesarean deliveries were performed by well- trained resident doctor supervised by
Assistant lecturer or Obstetrician consultant.
Cesarean section was performed under spinal anesthesia. Novasoconstrictor was used
unless the blood pressure dropped by 20% fromthe baseline value; if this was the
case, 10 mg ephedrine was given.
Cesarean Delivery technique was the same in all recruited women.
Abdominal skin incision was done through a Pfannenstiel incision 2 to 3cm above the
symphysis pubis, with the mid portion of the incision within the shaved area of the
pubic hair for a length of about 10-12cm was done. After the rectus fascia was
opened, the rectus
muscles were separated and dissected off the peritoneum which was
picked up between two tissue forceps and opened longitudinally. The visceral
peritoneum was dissected sharply and gently to separate the bladder from the
uterus. The
uterus was opened through a transverse lower segment incision.
After clamping of the umbilical cord, the women received 1.5 gm Ampicillin
-Sulbactam (Ultracillin, Sedico, Egypt) and 80 mg garamycin (Epigent, EPICO, EGYPT)
Uterine repair by absorbable continuous vicryl 1 sutures in two layers , parietal
peritoneum was sutured by absorbable continuous vicryl sutures, rectus sheath was
closed by absorbable continuous vicryl 1.
subcutaneous fatty layer was closed by absorbable continuous vicryl 0sutures, skin
was closed by vicryl 2-0 by subcuticular sutures.
All the towels were weighed before and after cesarean section and the difference
were calculated, the amount of intraoperative blood loss was estimated in the
suction apparatus in ml. A trained nurse was responsible for blood and amniotic
fluid collection during surgery using two separate suction sets, as well as for
weighing the surgical towels before and after surgery; all towels that were used
were of the same size and weight and every 1 gm increase in weight was equated with
1-mLblood loss. The total amount of intra-operative blood loss was
calculated.(blood loss in suction apparatus plus weight difference of used towels
Second trained nurse was responsible for post-operative external blood loss
measurement during the first 24 hours after surgery by weighing the soaked towels
placed in the vulvar area. The post-operative blood loss was calculated (weight
difference of towels placed in the vulvar area .The overall blood loss was
calculated. Another blood picture was obtained 24 hours postoperative to detect
changes in Hb level. The same nurse was responsible for follow up body temperature
2 hours after caesarean section (feverish if temperature is 38ºC or greater) and
observation of the patient for nausea , vomiting , chills and diarrhea.
Outcomes:
Primary outcomes: involved estimation of intraoperative and
postoperative blood loss for 24 hours ( blood loss estimation started immediately
following the skin incision)
Secondary outcomes:
Changes in hemoglobin concentration ( hemoglobin concentrations were measured 2
hours before surgery and 24 hours after surgery)
Misoprostol-induced maternal adverse effects (postoperativenausea, vomiting,
diarrhea, fever and chills .
Need to use other uterotonic drugs (oxytocin or ergometrine).Need to do further
surgical interventions ( uterine artery ligation ,hysterectomy or re-exploration of
the patient)
Need for blood transfusion.
Sample Size:
Sample size was calculated based on the primary outcome (the amount of
intraoperative blood loss during cs ) based on the results of previous study ,the
mean blood loss with the use of Iv oxytocinas588.9ml with a standerd deviation of
96.3 ml (10).
Assuming that buccal misoprostol is more effective in reducing blood loss by 10% 77
participants in each group will have 95% power at significance to detect such a 5%
difference
women were include in each group taking in account a 10% 77 drop-out rate
(Epi-info: centers for disease control and prevention
Atlanta, GA)
Approval of Ethical Considerations:
The Research Ethics Committee of Faculty of Medicine, Assiut
University approved the study protocol. Pregnant women who would
undergo elective lower segment cesarean section at term ( ≥ 37 weeks)
with normal fetal heart tracing received written and verbal information
about the study and were asked to participate. Those who agreed signed
an informed consent form
Statistical Analysis:
Data entry and analysis were carried out using Statistical Package
of Social Sciences for windows (SPSS, Chicago, Illinois, USA) version 20
Quantitative variables were presented in terms of mean± standard
deviation and qualitative variables were expressed as frequency and
percentage. Tests of significance (T-test and chi-square) were calculated
Significance level was set at P value < 0.05.
