Cervical Traction vs. Active Management of 3rd Stage of Labor

NCT ID: NCT04747015

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-13

Study Completion Date

2021-12-31

Brief Summary

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306 patients will be divided randomly in to 2 GROUPS:

* control group: 153 patients will receive Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby for both groups in prevention of postpartum haemorrhage,followed by active management of the third stage of labor by administration of oxytocin 5 IU units IM and waiting for signs of placental separation then controlled cord traction (CCT) to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver)
* study group:156 patients received Oxytocin 10 IU I.V shot at the time of delivery of the of the anterior shoulder of the baby according to the WHO recommendation .Then oxytocin is stopped and cervical traction (Amr maneuver )is applied.

In the maneuver,sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds. The traction should be adequate to allow the cervix to reach the vaginal introitus. Meanwhile (CCT ) is avoided and watchful waiting for signs of placental separartion till 90 seconds end. Massage is not employed but the fundus is frequently palpaple to insure it doesnot become atonic and filled with blood from placenta separation. In cases whom placental separation did not occur within the 90 seconds, we removed the ovum forceps and waited for 30 min for the placental separation .

Detailed Description

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The patients were divided randomly in to 2 GROUPS:

* control group: 153 patients received Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby according to the WHO recommendation for both groups in prevention of postpartum haemorrhage,followed by active management of the third stage of labor by administration of oxytocin 5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation then controlled cord traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver)
* study group:156 patients received Oxytocin 10 IU I.V shot at the time of delivery of the of the anterior shoulder of the baby according to the WHO recommendation .Then oxytocin is stopped and cervical traction (Amr maneuver )is applied.

In the maneuver,sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds. The traction should be adequate to allow the cervix to reach the vaginal introitus. Meanwhile (CCT ) is avoided and watchful waiting for signs of placental separartion till 90 seconds end. Massage is not employed but the fundus is frequently palpaple to insure it doesnot become atonic and filled with blood from placenta separation. In cases whom placental separation did not occur within the 90 seconds, we removed the ovum forceps and waited for 30 min for the placental separation .

Conditions

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Post Partum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cervical traction

sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds. The traction should be adequate to allow the cervix to reach the vaginal introitus

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation then controlled cord traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver)

cervical traction

Intervention Type PROCEDURE

sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds. The traction should be adequate to allow the cervix to reach the vaginal introitus. Meanwhile (CCT ) is avoided and watchful waiting for signs of placental separartion till 90 seconds end

Active management

administration of oxytocin 5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation then controlled cord traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver)

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby according to the WHO recommendation

Oxytocin

Intervention Type DRUG

5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation then controlled cord traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver)

Interventions

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Oxytocin

Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby according to the WHO recommendation

Intervention Type DRUG

Oxytocin

5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation then controlled cord traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver)

Intervention Type DRUG

cervical traction

sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds. The traction should be adequate to allow the cervix to reach the vaginal introitus. Meanwhile (CCT ) is avoided and watchful waiting for signs of placental separartion till 90 seconds end

Intervention Type PROCEDURE

Other Intervention Names

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Routine oxytocin Active management Amr maneuver

Eligibility Criteria

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Inclusion Criteria

singleton pregnancy full term pregnancy ( gestational age 37 - 42 weeks).

Exclusion Criteria

* twin pregnancy, preterm labor \<36 weeks, fetal macrosomia, any case with bleeding tendency e.g: haemorrhagic diseases and cases with risk of postpartum haemorrhage as: Peripartun hemorrhage ( placenta previa or placental abruption), anemia or hypertension
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed M Maged, MD

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Maged, MD

Role: CONTACT

+201005227404

Ali Abdelhafez, MD

Role: CONTACT

+201001845356

Facility Contacts

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Ahmed Maged, MD

Role: primary

01005227404

Other Identifiers

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61

Identifier Type: -

Identifier Source: org_study_id

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