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Trial Outcomes & Findings for Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption (NCT NCT00120042)

NCT ID: NCT00120042

Last Updated: 2009-07-09

Results Overview

If spontaneous expulsion of the placenta within 60 minutes of fetal delivery did not occur, digital exploration of the uterus in the operating room was planned.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

251 participants

Primary outcome timeframe

3 years

Results posted on

2009-07-09

Participant Flow

Participant milestones

Participant milestones
Measure
1
No specific oxytocic to assist in placental delivery
2
Intramuscular oxytocin injection
3
Oral misoprostol to assist in placental delivery
Overall Study
STARTED
85
83
83
Overall Study
COMPLETED
85
83
83
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
1
No specific oxytocic to assist in placental delivery
2
Intramuscular oxytocin injection
3
Oral misoprostol to assist in placental delivery
Overall Study
all completed protocl
0
0
0

Baseline Characteristics

Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
1
n=85 Participants
No specific oxytocic to assist in placental delivery
2
n=83 Participants
Intramuscular oxytocin injection
3
n=83 Participants
Oral misoprostol to assist in placental delivery
Total
n=251 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0.0 Participants
n=7 Participants
Age, Categorical
Between 18 and 65 years
85 Participants
n=99 Participants
83 Participants
n=107 Participants
83 Participants
n=206 Participants
251.0 Participants
n=7 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0.0 Participants
n=7 Participants
Age Continuous
32 years
n=99 Participants
32 years
n=107 Participants
30 years
n=206 Participants
32 years
n=7 Participants
Sex: Female, Male
Female
85 Participants
n=99 Participants
83 Participants
n=107 Participants
83 Participants
n=206 Participants
251.0 Participants
n=7 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0.0 Participants
n=7 Participants
Region of Enrollment
Australia
85 participants
n=99 Participants
83 participants
n=107 Participants
83 participants
n=206 Participants
251.0 participants
n=7 Participants

PRIMARY outcome

Timeframe: 3 years

If spontaneous expulsion of the placenta within 60 minutes of fetal delivery did not occur, digital exploration of the uterus in the operating room was planned.

Outcome measures

Outcome measures
Measure
1
n=85 Participants
No specific oxytocic to assist in placental delivery
2
n=83 Participants
Intramuscular oxytocin injection
3
n=83 Participants
Oral misoprostol to assist in placental delivery
Placental Retention Rate
26 participants
8 participants
24 participants

SECONDARY outcome

Timeframe: 3 years

Blood loss was assessed by weighing of pads and sheets in addition to clot

Outcome measures

Outcome measures
Measure
1
n=85 Participants
No specific oxytocic to assist in placental delivery
2
n=83 Participants
Intramuscular oxytocin injection
3
n=83 Participants
Oral misoprostol to assist in placental delivery
Post-Delivery Blood Loss
200 mls
Interval 100.0 to 375.0
100 mls
Interval 50.0 to 200.0
200 mls
Interval 100.0 to 375.0

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome data not reported

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Jan Dickinson

The University of Western Australia

Phone: 61-8-93401330

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place