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Trial registered on ANZCTR


Registration number
ACTRN12615000469516
Ethics application status
Approved
Date submitted
18/02/2015
Date registered
13/05/2015
Date last updated
13/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of obstetric gels on the labor process and duration in pregnant women
Scientific title
The effect of obstetric gels on the labor process and duration in pregnant women
Secondary ID [1] 286202 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vaginal birth 294238 0
Condition category
Condition code
Reproductive Health and Childbirth 294554 294554 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All women included to the study received standard routine antepartum care in delivery room. In this context, obstetric residency trainer (medical doctor) or obstetrician (specialist) attended all the vaginal exams, all the application of the obstetric gel, all the deliveries, and episiotomy (selectively) in our institution as an educational university clinic. All the pregnant women examined vaginally at least every hour until to the end of the first stage, and than examination frequency changed depend on the labor progress in the second stage of the labor. Continue fetal monitorization was performed with tococardiograph until to the delivery. Maternal and fetal parameters were recorded on partograph during labor. All the pregnant women included and received standard antepartum care randomly assigned to either two groups at the first stage of the labor.
Pregnant women in group A underwent a standard antepartum care plus vaginal application of the obstetric gel according to the study protocol. A specially designed sterile obstetric gel which has properties of high mucoadhesive activity, high viscosity, electric conductivity and non-allergenic was used for the study (Gynotal Obstetric – Registered Trademark). The obstetric gel is based on cross-linked polyacrylic acid, hydroxyethylcellulose and propylene glycol and is free of preservatives. The obstetric gel was intermittently applied into the vaginal canal with special applicator beginning early first stage of labor (prior to 4 cm cervical dilation) and ended with the delivery of the baby. 3-5 ml of gel were administered and evenly distributed in the vagina every two hours at examination using a sterile glove by obstetric residency trainer (medical doctor) or obstetrician (specialist). Only one box containing 2 pieces syringes (12ml) labeled as “Stage A” and 1 piece syringe (12ml) labeled as “Stage B” was used for during delivery and limited for each patient. Syringes labeled as “Stage A” and syringe labeled as “Stage B” were performed for the active phase of first stage, and the second stage of labor, respectively. No perineal massage was performed.
Intervention code [1] 291216 0
Treatment: Other
Comparator / control treatment
All women included to the study received standard routine antepartum care in delivery room. In this context, obstetric residency trainer (medical doctor) or obstetrician (specialist) attended all the vaginal exams, all the application of the obstetric gel, all the deliveries, and episiotomy (selectively) in our institution as an educational university clinic. All the pregnant women examined vaginally at least every hour until to the end of the first stage, and than examination frequency changed depend on the labor progress in the second stage of the labor. Continue fetal monitorization was performed with tococardiograph until to the delivery. Maternal and fetal parameters were recorded on partograph during labor. All the pregnant women included and received standard antepartum care randomly assigned to either two groups at the first stage of the labor.
Pregnant women in group B, which is control group for the study underwent standard antepartum care without use of any obstetric gel.
Control group
Active

Outcomes
Primary outcome [1] 294334 0
Length of the active phase of first stage of labor assessed by recording the period from the beginning to end of the active phase of first stage of labor.
Timepoint [1] 294334 0
During first stage of labor
Primary outcome [2] 294792 0
Length of the second stage of labor assessed by recording the period from the beginning to end of the second stage of labor.
Timepoint [2] 294792 0
During second stage of labor
Secondary outcome [1] 313060 0
The number and types of Perineal lacerations by performing physical-pelvic examination, no any specific laboratory test or tool. This is a composite outcome.
Timepoint [1] 313060 0
During The Labor

Eligibility
Key inclusion criteria
* Singleton baby in vertex presentation
* Low risk pregnancy
* Normoweight fetus (clinically or by sonography)
* Term pregnancy
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Indication for cesarean delivery
* Macrosomia
* Contraindication for vaginal delivery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2014
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
20/03/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 6673 0
Turkey
State/province [1] 6673 0

Funding & Sponsors
Funding source category [1] 290772 0
Commercial sector/Industry
Name [1] 290772 0
Turkuaz Saglik Hizmetleri, Medikal, Temizlik, Kimyasal Urunler San. ve Tic. Ltd. St.
Country [1] 290772 0
Turkey
Primary sponsor type
Commercial sector/Industry
Name
Turkuaz Saglik Hizmetleri, Medikal, Temizlik, Kimyasal Urunler San. ve Tic. Ltd. St.
Address
Saadetdere Mah. 27 sokak No:3 34100 Esenyurt Istanbul Turkey
Country
Turkey
Secondary sponsor category [1] 289456 0
None
Name [1] 289456 0
None
Address [1] 289456 0
None
Country [1] 289456 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292403 0
Ankara University Medical Faculty Instituonal ethics Committee
Ethics committee address [1] 292403 0
Ankara Universitesi Tip Fakultesi Dekanligi
Klinik Arastirmalar Etik Kurulu 06100 Sihhiye ANKARA
Ethics committee country [1] 292403 0
Turkey
Date submitted for ethics approval [1] 292403 0
15/04/2013
Approval date [1] 292403 0
01/08/2013
Ethics approval number [1] 292403 0
11-425-13

Summary
Brief summary
We aimed to investigate the effects of the obstetric gels on the labor process, and perineum after vaginal birth in this study.
A total of 200 women with singleton low-risk pregnancies in vertex position at term were recruited for the randomized controlled study. All the pregnant women included and received standard antepartum care randomly assigned to either two groups at the first stage of the labor. Pregnant women in group A underwent a standard antepartum care plus vaginal application of the obstetric gel according to the study protocol. Pregnant women in group B, which is control group for the study underwent standard antepartum care without use of any obstetric gel. The obstetric gel was intermittently applied into the vaginal canal with special applicator beginning early first stage of labor (prior to 4 cm cervical dilation) and ended with the delivery of the baby. 3-5 ml of gel were administered and evenly distributed in the vagina every two hours at examination using a sterile glove by obstetric residency trainer (medical doctor) or obstetrician (specialist).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55046 0
Dr Mehmet Murat Seval
Address 55046 0
Ankara University Medical Faculty
Department of Obststrics and Gynecology
Cebeci Hospital, 06620, Mamak,
Ankara
Country 55046 0
Turkey
Phone 55046 0
+90 312 595 68 58
Fax 55046 0
Email 55046 0
[email protected]
Contact person for public queries
Name 55047 0
Mr Nizamettin Uzunkol
Address 55047 0
Ankara University Medical Faculty, cebeci Hospital, 06620, Mamak, Ankara
Country 55047 0
Turkey
Phone 55047 0
+90 312 595 64 05
Fax 55047 0
Email 55047 0
[email protected]
Contact person for scientific queries
Name 55048 0
Dr Sabri Cavkaytar
Address 55048 0
Zekai Tahir Burak Women' Health Research and Education Hospital, Gurpinar sokak 4/8, 06260, Cebeci, Ankara
Country 55048 0
Turkey
Phone 55048 0
+90 312 306 55 52
Fax 55048 0
Email 55048 0
[email protected]

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