NCT01931423

Brief Summary

To determine whether early placental drainage plus cord traction reduces the incidences of manual removal and blood loss, and to determine the risk factors associated with blood loss after delivery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
485

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 10, 2014

Status Verified

November 1, 2013

Enrollment Period

3 months

First QC Date

August 26, 2013

Last Update Submit

March 7, 2014

Conditions

Postpartum Haemorrhage

Outcome Measures

Primary Outcomes (1)

  • postpartum blood loss

    24 hours

Study Arms (2)

Drainage Group

PLACEBO COMPARATOR

early placental drainage plus cord traction

Behavioral: Placental cord drainage

Controlled Group

NO INTERVENTION

spontaneous removal placenta

Interventions

Placental cord drainageBEHAVIORAL
Drainage Group

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • greater than 37 gestational weeks
  • single pregnancy
  • vaginal delivery
  • estimated fetal weight 2500-4500 gr.

You may not qualify if:

  • PPROM
  • or lower gestational week
  • multiple pregnancy
  • grand multiparıty (greater than 5)
  • coagulation defects (HELLP, ablation placenta, previa, pre-eclampsia)
  • a history of any bleeding during pregnancy
  • caesarean delivery or any uterine scar
  • a history of postpartum haemorrhage
  • hydramnios
  • known uterine anomalies
  • suspected abnormal placentation (accreta, increta, or percreta)
  • prepartum hemoglobin concentration less than 8 g/dL
  • history of anticoagulant drugs and prolongation of the first stage of labor longer than 15 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osman Aşıcıoğlu

Istanbul, ŞiŞLİ, 32744, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Osman Aşıcıoğlu, M.D.

    T.C.S.B. Şişli Etfal Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Obstetric and Gynecology

Study Record Dates

First Submitted

August 26, 2013

First Posted

August 29, 2013

Study Start

November 1, 2013

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

March 10, 2014

Record last verified: 2013-11

Locations

TU(1)