NCT01932957

Brief Summary

Standard management for patients with ruptured ectopic pregnancies at our institution is treatment by laparotomy. This trail will investigate the feasibility of treatment with laparoscopy and will look at outcomes such as hospital stay and pain experienced The hypothesis is that laparoscopy is a feasible treatment option associated with shorter hospital stay and less pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

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

Study Start

First participant enrolled

May 2, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2013

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

August 27, 2013

Last Update Submit

March 8, 2021

Conditions

Ruptured Ectopic Pregnancy

Keywords

LaparoscopyRuptured ectopic pregnancy

Outcome Measures

Primary Outcomes (1)

  • Hospital stay

    Hospital stay will be compared between the two groups

    5 days

Secondary Outcomes (2)

  • Pain scores

    24 hours

  • Theatre time

    1 day

Study Arms (2)

Laparotomy arm

OTHER

Standard treatment

Procedure: Laparotomy arm

Laparoscopy arm

EXPERIMENTAL

Treatment by laparoscopy

Procedure: Laparoscopy arm

Interventions

Laparotomy armPROCEDURE

Laparotomy as standard treatment for ruptured ectopic pregnancy

Laparotomy arm
Laparoscopy armPROCEDURE

Laparoscopy as treatment for ruptured ectopic pregnancy

Laparoscopy arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Able to give informed consent
  • must have two of the following three:
  • systolic blood pressure \>90 mmHg
  • pulse rate \<100 beats per minute
  • heamoglobin \>8 g/dL

You may not qualify if:

  • \<18 years
  • haemodynamically unstable
  • not able to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kalafong Academic Hospital

Pretoria, Gauteng, 0001, South Africa

Location

Study Officials

  • Leon C Snyman, MBChB FCOG

    Principal Specialist, Department Obstetrics & Gynaecology, University of Pretoria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 27, 2013

First Posted

August 30, 2013

Study Start

May 2, 2012

Primary Completion

October 31, 2013

Study Completion

November 30, 2013

Last Updated

March 11, 2021

Record last verified: 2021-03

Locations

ZA(1)