The aim of this study was to compare of Extra-amniotic Normal Saline plus Hydrocortisone infusion (EASHI) versus prostaglandin E2 suppository for second- trimester pregnancy termination.
A randomized clinical trial study was performed on 50 pregnant women with gestational age of 14-28 weeks and Bishop Score ≤ 2 who required pregnancy termination for fetal indications and randomly assigned to the two groups of 25.
In EASHI group (25 patients), a coworker inserted a No. 14 Foley catheter through the cervical canal and balloon was filled with 20 ml water and fixed. Then 360 ml sterile Normal Saline with 100 mg. Hydrocortisone was infused at a rate of 30 ml per hour into the extra amniotic space and continued up to 12 hours maximum.
The Prostaglandin group (25 patients) was received two doses of prostaglandin E2 intra vaginal suppository (Dinoprostone) 3mg every 4 hour.
In both groups, 6 hours after the last dose of prostaglandin and removal of Foley catheter, induction with high dose Oxytocin (according to Alabama University Protocol) was initiated up to 24 hours maximum.
Mean interval time between initiation of induction and delivery, success rate of pregnancy termination, need for curettage, complications such as fever, nausea, vomiting, diarrhea and increase of blood pressure were compared in two groups.
General information
Acronym
EASI
IRCT registration information
IRCT registration number:IRCT201109107520N1
Registration date:2011-12-29, 1390/10/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-29, 1390/10/08
Registrant information
Name
Farahnaz Keshavarzi
Name of organization / entity
Kermanshah University of Medical Sciences (KUMS)
Country
Iran (Islamic Republic of)
Phone
+98 83 3724 2893
Email address
fnkeshavarzi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences (KUMS)
Expected recruitment start date
2004-04-20, 1383/02/01
Expected recruitment end date
2005-01-20, 1383/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Extra-Amniotic Normal Saline Infusion plus Hydrocortisone versus Prostaglandin E2 Suppository for Pregnancy Termination
Public title
Extra-Amniotic Normal Saline Infusion plus Hydrocortisone versus Prostaglandin E2 Suppository for Pregnancy Termination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :Multiparus لreater than or equal to 4; Bishop Score less than or equal to 2; Gestational age 14-28 weeks; Amniotic sac intact; Fetal indication of Pregnancy Termination. Exclusion criteria : Placenta Previa; Uterus Anomalies; Rupture of Membrane; History of Hypertension; Fever; Cardiac Disease; Previous Scar on the Uterus; Drug Sensitivity (Prostaglandin E2 and Hydrocortisone); contraction of uterus.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for research, Kermanshah University of Medical Sciences (KUMS), Building No. 2, Shahid Beheshti Blvd
City
Kermanshah
Postal code
Approval date
2011-09-27, 1390/07/05
Ethics committee reference number
7/420/30233/P
Health conditions studied
1
Description of health condition studied
Induction of labor, termination of pregnancy
ICD-10 code
O04
ICD-10 code description
Medical abortion: Incl: termination of pregnancy: legal
Primary outcomes
1
Description
Mean time from initiation of induction till expultion of conception.
Timepoint
Hour
Method of measurement
Excretion products of pregnancy
Secondary outcomes
1
Description
The need to curettage
Timepoint
24 hours after fetus expultion
Method of measurement
Residual of conception based on ultrasonography
2
Description
Uterus hyperton
Timepoint
Hour
Method of measurement
The Uterine contractions of more than two minutes
3
Description
Placenta retention
Timepoint
Every 20 minutes
Method of measurement
Retention of placenta up to half an hour after expulsion of fetus
4
Description
Success rate of pregnancy termination
Timepoint
hour
Method of measurement
Expultion of pregnancy conception
5
Description
Diarrhea
Timepoint
Every 4 hours
Method of measurement
The passage of three or more loose or watery stools a day
6
Description
Fever
Timepoint
Every 4 hours
Method of measurement
Temperature above 38 ° C sublingual
7
Description
Hypertension
Timepoint
Every 4 hours
Method of measurement
Blood pressure greater than or equal to 140/90 mm Hg
8
Description
Hypotension
Timepoint
Every 4 hours
Method of measurement
Blood pressure less than 90/70 mm Hg
9
Description
Tachy systole
Timepoint
Hour
Method of measurement
More than 6 uterine contractions in ten minutes
10
Description
Nausea, vomiting
Timepoint
Every 4 hours
Method of measurement
Based on patient complaints and symptoms of disease by observing investigator
Intervention groups
1
Description
Prostaglandin group (25 patients) was received two doses of prostaglandin E2 intra vaginal suppository (Dinoprostone) 3mg every 4 hour. In both groups, 6 hours after the last dose of prostaglandin and removal of Foley catheter, induction with high dose Oxytocin (according to Alabama University Protocol) was initiated up to 24 hours maximum.
Category
Treatment - Drugs
2
Description
In EASHI group (25 patients), under sterile conditions, a coworker inserted a No. 14 Foley catheter through the cervical canal and balloon was filled with 20 ml water and fixed. Then 360 ml sterile Normal Saline with 100 mg. Hydrocortisone was infused at a rate of 30 ml per hours into the extra amniotic space. The Foley catheter was checked every hour for spontaneous expulsion. If it was tolerated by patients, the infusion continued up to 12 hours maximum. In both groups, 6 hours after the last dose of prostaglandin and removal of Foley catheter, induction with high dose Oxytocin (according to Alabama University Protocol) was initiated up to 24 hours maximum.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical Center of Motazedi
Full name of responsible person
Dr. Farahnaz Keshavarzi
Street address
Imam Reza Hospital, Parastar Blvd., Sorkheh Lyzheh, Kermanshah University of Medical Sciences (KUMS)
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Kermanshah University of Medical Sciences (KUMS)
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for research, Building No. 2, Shahid Beheshti Blvd, Kermanshah University of Medical Sciences(KUMS)
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Kermanshah University of Medical Sciences (KUMS)
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences (KUMS)
Full name of responsible person
Dr. Farahnaz Keshavarzi
Position
Assistant Professor and Faculty Member of Kermanshah University of Medical Sciences