Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02723461 |
| Other study ID # |
pulsatile oxytocin |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
March 26, 2016 |
| Last updated |
September 19, 2016 |
| Start date |
March 2016 |
| Est. completion date |
February 2017 |
Study information
| Verified date |
September 2016 |
| Source |
Ain Shams Maternity Hospital |
| Contact |
Amr A Riad, MD |
| Phone |
01005347179 |
| Email |
amr.riad[@]med.asu.edu.eg |
| Is FDA regulated |
No |
| Health authority |
Egypt: Ministry of Health and Population |
| Study type |
Interventional
|
Clinical Trial Summary
Comparing continuous intravenous oxytocin infusion with pulsatile administration of
intravenous oxytocin for augmentation of the first stage of labor.
Description:
The study population comprises120 cases with spontaneous onset of labor who are admitted to
the labor ward at causalities of Ain shams university maternity hospital.
The required sample size has been calculated using the IBM© SamplePower© Software (IBM©
Corp., Armonk, NY, USA). A previous study by Tribe et al., 2012 reported that the mean
infusion to delivery time associated with continuous infusion of oxytocin was 7.17 hours
with a 95% confidence interval (95% CI) of 6.58 to 7.77 hours versus 9.61 hours (95% CI,
8.95 to 10.27 hours) in association with pulsatile oxytocin. The sample size for either
regimen in that study was 240 patients or 241 patients, respectively. From the study of
Tribe et al. (2012), it could be estimated that the standard deviation (SD) for the infusion
to delivery time was 4.66 hours or 5.23 hours for the continuous or pulsatile oxytocin
regimen, respectively. This calculation is derived from solving any of the following
equations for the SD given the mean, lower or upper 95% CI limit, and sample size:
Lower 95% CI limit = mean - (1.96 * SD / √n)..... Equation 1 Upper 95% CI limit = mean +
(1.96 * SD / √n…..Equation 2 where SD is the standard deviation and n is the sample size
(Chow et al., 2003).
So, it is estimated that a sample size of 66 patients in either study group (total, 132
patients) would achieve a power of 80% (type II error, 0.2) to detect a statistically
significant difference between the two groups as regards the infusion to delivery time using
a two-side unpaired Student t test with a confidence level of 95% (type I error, 0.05). the
mean ± SD infusion to delivery time in both groups is assumed to be identical and to equal
9.61 ± 5.23 hours under the null hypothesis. Under the alternative hypothesis, the mean ± SD
infusion to delivery time is assumed to equal 7.17 ± 4.66 hours in the continuous infusion
group versus 9.61 ± 5.23 hours in the pulsatile group.
This sample size of 66 patients in each study group would have a power of 93% (type II
error, 0.07) to detect a statistically significant difference between the two groups as
regards the rate of successful induction of labor for a medium effect size (w) of 0.3 using
a two-sided chi-squared test with a confidence level of 95% (type I error, 0.05). The effect
size (w) is calculated as follows:
w =√(χ^2/N), where χ2 is the chi-squared statistic and N is the total sample size. (Chow et
al., 2003).
Following admission, all patients will undergo complete clinical examination and detailed
medical history will be obtained as follows:
A. Personal history. B. Obstetric history: where the gestational age will be calculated by
the date of last menstrual period or by ultrasonography in unreliable dates.
C. Gynecological history.
Grouping:
The patients needing augmentation of first stage of labor will be divided equally into two
groups:
Group 1 (study group ; 60 patients ) :
Patients at labor are given augmentation by oxytocin in pulsatile method
Group 2 (control group ;60 patients) :
Patients at labor are given augmentation by oxytocin in continuous method
Intervention:
Pulsatile group:
Pulsatile infusion protocol using a programmable syringe pump is applied .The pulsatile
regime, oxytocin (Syntocinon,stock solution: 10 iU/mL) will be administered for 10 seconds
every 6 minutes and the dose (2 mU/pulse) will be doubled every 30 minutes until uterine
contractions will be established (3-4 in 10 minutes). This regime stems from the observation
that physiologic oxytocin may be released in a pulsatile fashion every 4-6 minutes (Dawood
et al.,1979)
Continuous group :
Continuous group will be administrated oxytocin (Syntocinon,stock solution: 10 iU/mL) at
starting dose (2 mU/min) in a continuous manner doubled every 30 minutes until uterine
contractions will be established (3-4 in 10minutes).
Then each patient will have case record form in which the following data will be recorded:
1. Patient initials.
2. Study number.
3. Group.
4. Parity.
5. Gestatinal age ( first day of last menstrual period - early ultrasound).
6. Rupture of membranes.
7. Duration of rupture of membranes.
8. Duration of first stage of labour.
9. Duration of second stage of labour.
10. Need for instrumental delivery.
11. Need for Cesarean section.
12. Adverse effect.
13. Neonatal outcome.
14. Maternal complications.
15. Adverse effect related to oxytocin.
16. Total dose of oxytocin infused.
17. Previous complicated vaginal delivery.
