Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04724187 |
| Other study ID # |
ARizwan |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
February 3, 2021 |
| Est. completion date |
August 30, 2021 |
Study information
| Verified date |
February 2021 |
| Source |
Islamabad Medical and Dental College |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Postpartum hemorrhage, is one of the most deadly complication of pregnancy worldwide and
major cause of maternal mortality especially in third world countries .1 PPH affects about 5%
of all women giving birth around the world 2 .Primary PPH is defined as ≥500 mL blood loss
after vaginal delivery or ≥1000 mL after CS delivery within 24 hours after birth1 . Globally,
almost one quarter of all maternal deaths are linked with PPH 2. Due to the high prevalence
of anemia among pregnant women in low-resource settings, the outcome of PPH is often
deteriorated, resulting in damaging health consequences 3. Roughly in 70% of cases of primary
pph are due to uterine atony11. Uterine atony is due to loss of contraction and retraction of
myometrial muscle fibers can lead to severe hemorrhage and shock. There are several reasons
behind uterine atony including maternal anemia, fatigue due to prolong labour and rapid
forceful labour. Blood loss is double in caesarean section due to use of increased anesthetic
agents4. According to WHO use of oxytocin (10 IU, IM /IV) is recommended for prevention of
PPH for all births2. Despite its effectiveness, 10-40% of cases need additional uterotonics
to ensure good uterine contraction.5 After oxytocin , Misoprostol is increasingly known as a
potential treatment option for PPH 5 .Misoprostol is easily available , rapid acting , and
cost effective with minimal side effects, however in caesarean section owing to the effect of
anesthesia limits its use . In recent study conducted at Egypt, oxytocin plus misoprostol
(study group) is compared with oxytocin alone (control group). Incident of pph was
significantly lower in study group (p=0.018), as in study group (1.33%) than control group
(6.67%)8. Misoprostol is an autacoid substance and act better if placed closed to target
organ 9. Several routes of misoprostol, with or without oxytocin, and its result on
intrapartum and postpartum hemorrhage are described in the literature. The practice of
misoprostol by the intrauterine route during caesarean section is under trial.10. Aim of
study is to observe the effectiveness of intrauterine misoprostol in addition to oxytocin to
minimize the blood loss during caesarean section.
Description:
Data will be collected from all the patients full filling inclusion criteria on especially
designed Performa after informed consent of patient, demographic data will be collected on
that preform Patients will be randomized and divide in to two groups group A ( study group )
and group B (controls) , patients under group A will be given 600 microgram misoprostol
through intra uterine route during lower segment caesarean section after delivery of placenta
in addition to oxytocin 10IU IV and Group B (control) only oxytocin 10IU IV will be given
according to WHO protocol .In both groups pre-operative hemoglobin done within 24 hours
before the surgery will be recorded and compared with post-operative hemoglobin estimated by
blood sample taken 48 hours after the surgery .Mean blood loss during caesarean section will
be documented by counting the number of towels , need of additional drugs (repeat oxytocin,
tranexamic acid, additional misoprostol) ,time of contractility of uterus, blood transfusion,
side effects of misoprostol that is fever, shivering, nausea, vomiting will be recorded 24
hours postoperative period.
All the collected data will be entered and analyzed by SPSS v. 21. Mean and standard
deviation will be calculated for quantitative variables like age, gestational age, BMI, pre
and post Hb, and blood loss during caesarean section. Frequencies along with percentages will
be presented for qualitative variables like need of additional drugs, and side effects of
misoprostol (fever, shivering, nausea, vomiting). Paired sample t-test will be used to
compare pre and post Hb levels of both groups. Independent sample t-test will be applied to
compare post Hb level, blood loss between both groups. Chi-square test will be employed to
compare side effects (fever, shivering, nausea, vomiting) between both groups. P-value ≤ 0.05
will be taken as significant.
