Protocol summary

Study aim
To Compare Effect of Amniotomy with Early and Delayed Infusion of Oxytocin in Nulliparous Women with Prolonged Labor on Labor Experience and Some Maternal and Neonatal Outcomes
Design
In this trial, 351 women will be equally allocated into three parallel groups receiving early or delayed oxytocine infusion, or routine intervention, using a stratified block randomization with block sizes of 3, 6 and 9.Consecutively numbered opaque sealed envelopes will be used for the allocation concealment.
Settings and conduct
In Al-Zahra and Taleghani teaching hospitals in Tabriz, eligible women will be allocated to one of the three study groups using stratified block randomization, after receiving informed written consent and will be continuously monitored until delivery and followed up until discharge.
Participants/Inclusion and exclusion criteria
Inclusion criteria: nulliparous women aged 18 years or more with singleton alive fetus at a gestational age of 37-41 weeks, cephalic presentation, normal cardiotocogram, and bishop score of 6 or more with cervical dilatation of 4-6 cm hospitalized for vaginal delivery and have dilatation progress of less than 1 cm/h for 3 h or dilatation arrest for 2 h along with weak uterine contractions (less than 3 contractions in 10 min), and intact amniotic sac or less than 30 min after its rupture. Exclusion criteria: history of any incisions on the uterus, abnormal pelvic dimensions, history of infertility, any genital infection interfering with vaginal delivery, estimated fetal weight of more than 4000 g, severe fetal anomalies interfering with vaginal delivery.
Intervention groups
Group 1- amniotomy and early infusion of oxytocin, Group 2 - amniotomy and delayed infusion of oxytocin, Group 3 - hospital routine intervention.
Main outcome variables
The interval between intervention initiation and vaginal delivery; Score of maternal satisfaction with labor process

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100414003706N32
Registration date: 2018-11-22, 1397/09/01
Registration timing: registered_while_recruiting

Last update: 2018-11-22, 1397/09/01
Update count: 0
Registration date
2018-11-22, 1397/09/01
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-21, 1397/08/30
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Amniotomy with Early and Delayed Infusion of Oxytocin on Birth Experiences and Some Maternal and Neonatal Outcomes in Nulliparous Women with Prolonged Labor: A Randomized Controlled Trial
Public title
Comparison of Effect of Early and Delayed Oxytocin Infusion on Some Maternal and Neonatal Outcomes in Prolonged Labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Nulliparous women during labor with alive singleton fetus at gestational age of 37-41 weeks, Aged 18 years or more, Body mass index of 18.5-30 kg/m2, Cephalic presentation of the fetus, Bishop score of 6 or more with cervical dilatation of 4-6 cm, Prolonged labor: progress of cervical dilatation less than 1 cm/h for 3 h or dilatation arrest for 2 h, with weak uterine contractions (less than 3 contractions in 10 min), Intact amniotic sac or a maximum of 30 min from its rupture, Normal cardiotocogram at the time of admission and recruitment.
Exclusion criteria:
History of any incisions on the uterus, Abnormal pelvic dimensions, Abnormal bleeding, Any abnormalities in the genital soft or bone tissue, History of infertility and use of any assisted reproductive techniques in the present pregnancy, Any genital tract infection interfering with vaginal delivery (including genital herpes, fever with unknown cause, ...), Maternal medical illness (diabetes, high blood pressure, heart diseases, epilepsy, ...), Abnormal volume of amniotic fluid, Sustained asynclitisme or persistant posterior position, Severe fetal scalp edema or molding, Estimated fetal weight of more than 4000 g Known severe fetal anomalies interfering with vaginal delivery (hydrocephalus, polycystic kidney and any large abdominal mass) diagnosed, Fetal intrauterine growth restriction (IUGR), Maternal speech, hearing and visual problems.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 351
Randomization (investigator's opinion)
Randomized
Randomization description
A stratified (based on the two study sites) block randomization with random block sizes of 3, 6, 9 and allocation ratio of 1:1:1 will be used to assign participants into the three groups; group 1: amniotomy with early oxytocin infusion, group 2: amniotomy with delayed oxytocin infusion, and group 3: hospital routine intervention. The sequence will be generated using a computerized program (Randomizer). To conceal the sequence, consecutively numbered opaque sealed envelopes will be used. The sequence generation and preparation of the envelopes will be done by a person not involved in participant recruitment or data collection.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
At the two intervention groups, amniotomy will be done for those with intact amniotic sac. A 500 ml ringer serum will then be administered for all of the participants with a controlled infusion pump. In the group with early oxytocin infusion, 5 IU of oxytocin, and in the group with delayed oxytocin infusion, 1 ml of distilled water will be added to the solution. The infusion will be started with 3 drops/min. Then, 3 drops will be added every 20 min until reaching number of uterine contractions to 3/10 min or reaching number of the droplets to 30/min. The investigators and participants will not be aware of the type of intervention (early or delayed) within the first 3 h. In cases with occurrence of any tachycystol or abnormal cardiotocogram, the serum will immediately be replaced with a plain serum ringer. After the 3 h, the serum will be discontinued in the both early and delayed groups and a re-examination will be done by the investigator. In absence of childbirth or inadequate uterine contractions after the 3 h, 5 IU of oxytocin in 500 ml ringer serum be infused for the delayed group, in the same way mentioned for the early infusion group. The third (control) group will receive routine intervention of the hospital.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Ave., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-10-22, 1397/07/30
Ethics committee reference number
IR.TBZMED.REC.1397.624

Health conditions studied

1

Description of health condition studied
Prolonged labor in nulliparous women
ICD-10 code
063.0
ICD-10 code description
Prolonged first stage of labour

Primary outcomes

1

Description
The interval between intervention initiation and vaginal delivery
Timepoint
After delivery
Method of measurement
Timer

2

Description
Score of maternal satisfaction with process of labor and birth
Timepoint
12-24 h after childbirth
Method of measurement
MacKey childbirth satisfaction rating scale

Secondary outcomes

1

Description
Mode of delivery
Timepoint
After delivery
Method of measurement
Using Medical record

2

Description
Uterine hyperstimulation
Timepoint
At intervals of one hour since the intervention initiation
Method of measurement
Palpation of uterine contractions for 10 min

3

Description
Maternal fever
Timepoint
Within 6 hours after delivery
Method of measurement
Thermometer (sublingual)

4

Description
Use of analgesic drugs in the first stage of labor
Timepoint
During intervention
Method of measurement
Observation and record

5

Description
Manual removal of placenta
Timepoint
After vaginal childbirth
Method of measurement
Observation

6

Description
Hemoglobin and hematocrit
Timepoint
At baseline and 12 hours after delivery
Method of measurement
Laboratory test

7

Description
Volume of postpartum hemorrhage
Timepoint
12 hours after delivery
Method of measurement
Using the Stafford formula

8

Description
Duration of the first stage of labor (from 4 to 10 cm cervical dilatation)
Timepoint
After completion of cervical dilatation
Method of measurement
Timer

9

Description
Duration of the second stage of labor (from completing cervical dilatation to fetal expulsion)
Timepoint
After fetal expulsion
Method of measurement
Timer

10

Description
Duration of the third stage of labor (from delivery of the baby until complete expulsion of the placenta)
Timepoint
After complete expulsion of the placenta
Method of measurement
Timer

11

Description
Abnormal cardiotocogram (late deceleration, variable deceleration)
Timepoint
During the intervention
Method of measurement
Cardiotocography audit sheet

12

Description
Admission in neonatal intensive care unit
Timepoint
At hospital discharge of the baby
Method of measurement
Hospital record

13

Description
Neonate Apgar score less than 7
Timepoint
5 minutes after birth
Method of measurement
Clinical examination

Intervention groups

1

Description
Intervention group 1 (early oxytocin infusion): If the amniotic sac is intact, amniotomy will be done with an amniotic hook by the investigator. Soon after, 5 IU of oxytocin in 500 ml ringer's solution will be administered by a controlled infusion pump. The infusion will be started with 3 drops/min. Then 3 drops will be added every 20 min until the number of contractions reaches 3/10 min or the number of droplets reaches 30/min.
Category
Treatment - Drugs

2

Description
Intervention group 2 (delayed oxytocin infusion): If the amniotic sac is intact, amniotomy will be done with an amniotic hook by the investigator. Soon after, a 500 ml plain ringer serum will be administered by a controlled infusion pump. The infusion will be started with 3 drops/min. Then, 3 drops will be added every 20 min. After 3 h, in absence of childbirth or inadequate uterine contractions, 5 IU of oxytocin in 500 ml ringer's solution will be infused with 3 drops/min. Then, 3 drops will be added every 20 min until the number of contractions reaches 3/10 min or the number of droplets reaches 30/min.
Category
Treatment - Drugs

3

Description
Control group: This group will receive routine intervention of the hospital that includes: amniotomy, oxytocin infusion, both, or expected management.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Medical Research & Training Hospital
Full name of responsible person
Jila Nahaee
Street address
Rah-Ahan Square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5183617845
Phone
+98 41 3442 4421
Email
taleghani.hosp@tbzmed.ac.ir
Web page address
https://taleghanihosp.tbzmed.ac.ir/

2

Recruitment center
Name of recruitment center
َAl-Zahra Medical Research & Training Hospital
Full name of responsible person
Jila Nahaee
Street address
Bage-Shomal Intersection, South Artesh Ave., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Fax
Email
alzahra@tbzmed.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem Jouyban
Street address
No. 2, Central building of the university, Golgasht street, Azadi Ave., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 7310 3335
Fax
+98 41 4280 3334
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Jila Nahaee
Position
PhD student in Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
South Shariati Ave., Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5137975846
Phone
+98 41 3479 6770
Email
jnahaee@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-charandabi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
South Shariati Ave., Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5137975846
Phone
+98 41 3479 6770
Email
alizades@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
South Shariati Ave., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5137975846
Phone
+98 41 3479 6770
Email
alizades@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All deidentified IPD can be shared.
When the data will become available and for how long
Starting soon after publication of the study results.
To whom data/document is available
Data will be available for researchers working in academic institutions, as well as to chief editor and reviewers of the submitted manuscript.
Under which criteria data/document could be used
The data will be available to researchers upon request and submission of the proposal to perform meta-analysis using IPD. Also, in exceptional cases, data will be made available to chief-editor of the journals for checking.
From where data/document is obtainable
Refer to the email addresses (jnahaee@yahoo.com, alizades@tbzmed.ac.ir).
What processes are involved for a request to access data/document
The requests should be sent by email and data will be available within two week.
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