A Comparative Study about Maternal and Neonatal Outcomes of Using Extra-Amniotic Saline Infusion and vaginal Misoprostol for Cervical Ripening and Labor Induction in Pregnant Women with Unfavorable Cervix
Comparison of the effects of vaginally administered Misoprostol with
extra-amniotic saline infusion on induction to delivery interval, maternal and neonatal outcomes inorder to achieve shorter and also safer method for labor induction
Design
Two arm parallel group randomised trial with 72 pregnant women in each group, randomized with computer-generated table of random
numbers.
Settings and conduct
This study was conducted in the labor ward of Kamali Hospital, Karaj, Iran. There was no blinding in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women with singleton pregnancy; Unfavorable cervix; cephalic presentation of the fetus; 28 weeks of gestational age or more.
Non-inclusion criteria: Pregnant women with contra-indications for labor induction; non-reassuring fetal status
Intervention groups
Intervention group 1:Vaginal Misoprostol; In this group, 25 micrograms of Misoprostol was administered every 4 hours up to 5 doses.
Intervention group 2: Extra-amniotic saline infusion; this group received intravenous Oxytocin along with a maximum 12-hour saline solution infusion through Foley catheters that were placed above the internal cervical os.
Main outcome variables
Time to delivery; Vaginal vs cesarean delivery; Maternal and neonatal outcomes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201024049128N1
Registration date:2020-12-01, 1399/09/11
Registration timing:registered_while_recruiting
Last update:2020-12-01, 1399/09/11
Update count:0
Registration date
2020-12-01, 1399/09/11
Registrant information
Name
Bita Badehnoosh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3222 2021
Email address
badehnoosh@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study about Maternal and Neonatal Outcomes of Using Extra-Amniotic Saline Infusion and vaginal Misoprostol for Cervical Ripening and Labor Induction in Pregnant Women with Unfavorable Cervix
Public title
Comparison of the Effectiveness of Intravaginal Misoprostol with Extra-Amniotic Saline Infusion in Labor Induction
Non-cephalic presentation
Adequate uterine contractions (3 contractions Lasting for 30sec/10 min)
Ruptured membranes
Cephalopelvic disproportion
Multiple pregnancy
Polyhydramnios
Estimated fetal weight ≥4000g or ≤1800g
Placental abruption, Placenta previa
Unexplained vaginal bleeding
Prior lower segment cesarean section/Scarred uterus
Non-reassuring fetal status
Clinically detected vaginal infections(exp:genital herpes) or chorioamnionitis
Latex or Prostaglandins allergy or any contraindications receiving Prostaglandins, including a history of asthma, glaucoma, or cardiovascular disease
Intrauterine fetal death
Renal or hepatic failure
Age
No age limit
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Women who consented to participate were randomly selected to receive either Misoprostol or Extra-amniotic Saline Infusion. Group assignment was
determined from a computer-generated table of random
numbers.Some opaque envelopes were used for concealment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Ethics committee unit; Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2020-10-10, 1399/07/19
Ethics committee reference number
IR.ABZUMS.REC.1399.185
Health conditions studied
1
Description of health condition studied
Unfavorable cervix
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The mean time interval from start of induction to delivery
Timepoint
Time of birth
Method of measurement
Clock
2
Description
Duration of latent phase
Timepoint
At the end of latent phase
Method of measurement
Clock
3
Description
Duration of active phase
Timepoint
At the end of active phase
Method of measurement
clock
4
Description
Rate of delivery within 12 hours
Timepoint
At the end of study
Method of measurement
Patient's file
5
Description
Rate of delivery within 24 hours
Timepoint
At the end of study
Method of measurement
Patient's file
Secondary outcomes
1
Description
Cesarean rate
Timepoint
At the end of study
Method of measurement
Patient's file
2
Description
Incidence of tachysystole
Timepoint
Continuously
Method of measurement
Cardiotocography
3
Description
Incidence of hypertonus
Timepoint
Continuously
Method of measurement
Cardiotocography
4
Description
Apgar score
Timepoint
1 minute and 5 minutes after birth
Method of measurement
Examination of the newborn
5
Description
Incidence of meconium passage
Timepoint
At birth
Method of measurement
Examination of the newborn
6
Description
Incidence of chorioamnionitis
Timepoint
Every 3 hours
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: Vaginal Misoprostol. Misoprostol is a prostaglandin E1 analog known to stimulate uterine contractions. In this study 100-microgram tablets were used. In this intervention group, 25 micrograms of misoprostol (1/4 of 100-microgram tablet) was inserted intravaginally in the posterior fornix every 4 hours up to 5 doses. The maximal cervical ripening period until labor induced was 24 hours, regardless of the number of doses received. Intravenous oxytocin was given to the misoprostol group for the following reasons:(1) active labor did not occur after the maximum number of doses of misoprostol had been given, (2) spontaneous rupture of the membranes occurred without anadequate contraction pattern, or (3) dilation was arrested (no change in cervical dilation for >2 hours)
Category
Treatment - Drugs
2
Description
Intervention group: Extra-amniotic saline infusion. Saline is a type of isotonic solution and a mixture of salt and water. The concentration is 9 grams per litre (0.9% saline) . In this group, women underwent a speculum examination. After preparation of the cervix with Betadine solution, an18-gauge Foley catheter balloon was inserted to above the internal cervical os. The balloon was inflated to 30 milliliters with sterile normal saline solution, the Foley catheter was taped to the inner aspect of the subject’s thigh without any traction. A normal saline solution infusion of 30 mL per hour through the central lumen of the Foley catheter was initiated concurrently with intravenous oxytocin. Oxytocin infusion was started at a rate of 1.0 milliunits per minutes and was increased in nine stepwise increments to a maximum of 22.0 milliunits per minutes at 30-minute intervals as needed to achieve an adequate contraction pattern. The Foley catheter was removed for the following reasons: (1) 12 hours had elapsed since the initial placement (2) spontaneous rupture of membranes occurred, (3) evidence of fetal distress was noted, (4) the catheter was expelled spontaneously, or (5) the patient could no longer tolerate the procedure.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali hospital
Full name of responsible person
Bita Badehnoosh
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
b_badehnoosh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Nourisepehr
Street address
Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Bita Badehnoosh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
b_badehnoosh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Bita badehnoosh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
b_badehnoosh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Bita badehnoosh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
b_badehnoosh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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