Protocol summary

Summary
The effect of placental drainage after spontaneous vaginal delivery on third stage of labour Objective: To assess the effect of placental cord drainage on the duration of third stage of labor, and to clarify the safety of this method regarding to postpartum hemorrhage, retained placenta, incidence of manual removal of placenta, atony. Inclusion criteria: Natural vaginal delivery; pregnancy with vertex presentation ; Term pregnancy (37-42 weeks); Singelton pregnancy; Absence placental disorders and neonatal congenital anomaly in perinatal ultrasound examination; The absence of medical and obstetric conditions in the mother. Exclusion criteria: previous history of curtage; Instrumental delivery(Vacum ,Forceps); Maternal coagulation disorder. Material and Method: Four hundred women having vaginal delivery were divided into drainage group(200 women) and control group (200 women) .In both groups, management of third stage of labour was performed with active method and for removal of placenta was used Brandt- Andrew method with maternal pushing. The duration of third stage was compared as the primary outcome. The incidence of postpartum hemorrhage, retained placenta, incidence of manual removal of placenta, atony were compared. Keywords: Third stage of labor, Placental cord drainage, Postpartum hemorrhage, Retained placenta, Manual removal of placenta.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014041917341N1
Registration date: 2017-10-15, 1396/07/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Nazi Karimi
Name of organization / entity
Islamic Azad University .Isfahan(Khorasgan) Branch
Country
Iran (Islamic Republic of)
Phone
+98 31 3568 8824
Email address
karimi_nazli@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice-Presidency Of Isfahan(Khorasgan) Islamic Azad University
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of placenta drainage and routin Method of removal of placenta on the outcome of third Stage of Delivery.
Public title
The effect of placental drainage on the duration of third stage of labour
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Natural vaginal delivery; pregnancy with vertex presentation ; Term pregnancy (37-42 weeks); Singelton pregnancy; Absence placental disorders and neonatal congenital anomaly in perinatal ultrasound examination; The absence of medical and obstetric conditions in the mother. Exclusion criteria: previous history of curtage; Instrumental delivery(Vacum ,Forceps); Maternal coagulation disorder.
Age
From 16 years old to 43 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 400
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
Najafabad Islamic Azad University
Street address
University Sq, Najafabad, Isfahan, Iran
City
Najafabad
Postal code
Approval date
2017-08-22, 1396/05/31
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1396.39

2

Ethics committee
Name of ethics committee
Isfahan (Khorasgan) Islamic Azad University
Street address
University Blvd, Argavaniyeh, Jay street.
City
Isfahan
Postal code
Approval date
2017-08-22, 1396/05/31
Ethics committee reference number
96-04-14-5-4513

Health conditions studied

1

Description of health condition studied
Outcome of third stage of labour
ICD-10 code
O72,O73,O7
ICD-10 code description
Postpartum haemorrhage,Retained placenta and membranes, without haemorrhage,Other complications of labour and delivery, not elsewhere classified

Primary outcomes

1

Description
duration of 3rd stage of delivery
Timepoint
At the same time study
Method of measurement
Using a stopwatch in seconds

Secondary outcomes

1

Description
Retained placenta
Timepoint
At the same time study
Method of measurement
The presence or absence of retention

2

Description
Manual removal of placenta
Timepoint
At the same time study
Method of measurement
The number of cases of Manual removal of placenta

3

Description
Postpartum hemorrhage
Timepoint
At the same time study
Method of measurement
Just a visual check

Intervention groups

1

Description
Routine intervention active management of third stage of labour (the control group): Immediately after the birth of the baby, the umbilical cord is clamped with two forceps (at a distance of 4-5 cm in the fetus) and cut between them and the baby is placed in the baby's cot. 20 units of oxytocin immediately after delivery of the baby is injected at 1000 cc of the ringer's syringe and infused with a velocity of 20-10 ml / min (200-200 ml / min),then clamped and cut umbilical cord of baby and from that time on, we calculate the time with the stopwatch, Check signs of placental separation, For up to 30 minutes, we allow placenta to be separated spontaneously and after the signs of separation of the placenta, With one hand, hold the uterus from the abdomen and with another hand pull it down with a cord (Brandt- Andrew maneuver), and at the same time encourages the mother push to delivery of placenta. After the delivery of the placenta, take it with two hands and turn it until the membrance are screwed and we pull out all membrance with a gentle stretch. At this time, stop the stopwatch . thus, the length of the third stage of labor is determined. Then massage the uterus and make sure of its contraction. Then check the placenta and membrance to make sure that it is complete. In the absence of delivery of placenta up to 30 minutes or a large bleeding, the Manual removal of placenta is done.
Category
Prevention

2

Description
Placental cord drainage active management of third stage of labour( In the study group): All actions in this group are as before. Only after the birth of a baby When the cord clamped and cut it and put the baby in the baby's cot, unclamped the cord and left open to drain blood in a vessel until flow ceased. Cord is slightly wrinkled ( placenta drainage). And the rest of the actions are the same as the control group. Up to one hour after the delivery of the placenta in both groups, the uterus contraction and the rate of receiving uterotonic drugs are checked.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Hospitals
Full name of responsible person
Molaie Ghazaleh
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Vice-Presidency Of Isfahan(Khorasgan) Islamic Azad University
Full name of responsible person
Masah Ahmadreza
Street address
University Blvd, Argavaniyeh, Jey street.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice-Presidency Of Isfahan(Khorasgan) Islamic Azad University
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
Isfahan (Khorasgan) Islamic Azad University
Full name of responsible person
Karimi Nazi
Position
MS
Other areas of specialty/work
Street address
University Blvd, Argavaniyeh, Jay street.
City
Isfahan
Postal code
Phone
+98 31 3535 4001
Fax
Email
karimi_nazli@khuisf.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan (Khorasgan) Islamic Azad University
Full name of responsible person
Karimi Nazi
Position
MS
Other areas of specialty/work
Street address
University Blvd, Argavaniyeh, Jay street.
City
Isfahan
Postal code
Phone
+98 31 3568 8824
Fax
+98 31 3535 4065
Email
karimi_nazli@khuisf.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan (Khorasgan) Islamic Azad University
Full name of responsible person
Karimi Nazi
Position
MS
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
Phone
Fax
Email
karimi_nazli@khuisf.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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