UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025363
Receipt number R000029196
Scientific Title Pre-operative or post-operative misoprostol in ceasrean delivery:Dose it differ?
Date of disclosure of the study information 2017/01/01
Last modified on 2016/12/21 21:33:09

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Basic information

Public title

Pre-operative or post-operative misoprostol in ceasrean delivery:Dose it differ?

Acronym

Pre-operative or post-operative misoprostol in cesarean delivery: Doseit differ?

Scientific Title

Pre-operative or post-operative misoprostol in ceasrean delivery:Dose it differ?

Scientific Title:Acronym

Pre-operative or post-operative misoprostol in cesarean delivery: Doseit differ?

Region

Africa


Condition

Condition

Finished

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

comparison of preoperative versus postoperative administration of misoprostol rectally in minimizing intraoperative blood loss and prevention of postpartum hemorrhage

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase IV


Assessment

Primary outcomes

amount of blood loss intraoperative and postoperative

Key secondary outcomes

Drop in hematocrite level 24 hours after cesarean section and any drug related complications


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Preoperative misoprostol received 400 microgram misoprostol after anesthesia at time catheter fixation

Interventions/Control_2

postoperative misoprostol received 400microgram misoprostol after the end of cesarean section

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

37 years-old >=

Gender

Female

Key inclusion criteria

full term pregnancy 37-40 weeks
planned elective cesarean delivery
regional spinal anesthesia

Key exclusion criteria

conditions prolonging surgical time or causing atony as: general anesthesia , antepartum hemorrahge
coagulation disorders
Previous 2 or more cesarean sections
previous rupture uterus
muliple pregnancies, polyhydramios or macrosomia

Target sample size

180


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ayman Shehata Dawood

Organization

Tanta University

Division name

Ayman Shehata Dawood

Zip code


Address

Tanta University, Faculty of Medicine, Department of Obstetrics and Gynecology, Tanta, Al Gharbia, Egypt

TEL

00201020972067

Email

ayman.dawood@med.tanta.edu.eg


Public contact

Name of contact person

1st name
Middle name
Last name Ayman Shehata Dawood

Organization

Tanta University

Division name

Ayman Shehata Dawood

Zip code


Address

Tanta University, Faculty of Medicine, Department of Obstetrics and Gynecology, Tanta, Al Gharbia, E

TEL

00201020972067

Homepage URL


Email

ayman.dawood@med.tanta.edu.eg


Sponsor or person

Institute

Tanta University

Institute

Department

Personal name



Funding Source

Organization

Tanta University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

Hesham M Borg

Org. issuing International ID_1

Tanta University

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 01 Day

Last follow-up date

2017 Year 01 Month 01 Day

Date of closure to data entry

2017 Year 01 Month 01 Day

Date trial data considered complete

2017 Year 01 Month 01 Day

Date analysis concluded

2017 Year 01 Month 01 Day


Other

Other related information



Management information

Registered date

2016 Year 12 Month 21 Day

Last modified on

2016 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029196


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name