Effect of intra-venous ocytocine injection after fetal expulsion in management of third-stage of labor after second trimester medical pregnancy termination

Effect of intra-venous ocytocine injection after fetal expulsion in management of third-stage of labor after second trimester medical pregnancy termination - ANDDROID

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003143-11-FR

Enrollment

114

Registered

2016-08-12

Start date

2016-10-27

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

second trimester medical pregnancy termination MedDRA version: 19.0 Level: LLT Classification code 10043285 Term: Termination of pregnancy - medical System Organ Class: 100000004865

Interventions

Trade Name: SYNTOCINON 5 U.I/1 ml, solution injectable en ampoule Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Women over 18 • to use a medical termination of pregnancy between 14 and 28 weeks of amenorrhea • affiliated person or beneficiary of a social security scheme. • Free, informed and writing signed by the participant and the investigator (no later than the day of inclusion and foremost need examination by research). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 114 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • fetal death in utero • pre-existing cardiovascular disease • minor patients • Contraindications to the use of oxytocin according to the summary of product characteristics. • Denial of participation in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary outcome: incidence of placental retention between the two groups defined by the absence of spontaneous expulsion of the placenta within 30 minutes.;Secondary Objective: The study aims to evaluate: - A decrease in the incidence of partial placental retention - A decrease in the incidence of digital exploration - A decrease in the incidence of blunt curettage - An Improved uterine vacuity after delivery (spontaneous or manual) - A decrease in blood loss: comparison of blood loss in the 2 groups - A decrease in the incidence of postpartum hemorrhage (PPH) in the 2 groups;Primary end point(s): complete placental retention rates after 30 minutes and / or necessity of artificial delivery.;Timepoint(s) of evaluation of this end point: The day of medical pregnancy termination	—

Measure

Time frame

Main Objective: Primary outcome: incidence of placental retention between the two groups defined by the absence of spontaneous expulsion of the placenta within 30 minutes.;Secondary Objective: The study aims to evaluate: - A decrease in the incidence of partial placental retention - A decrease in the incidence of digital exploration - A decrease in the incidence of blunt curettage - An Improved uterine vacuity after delivery (spontaneous or manual) - A decrease in blood loss: comparison of blood loss in the 2 groups - A decrease in the incidence of postpartum hemorrhage (PPH) in the 2 groups;Primary end point(s): complete placental retention rates after 30 minutes and / or necessity of artificial delivery.;Timepoint(s) of evaluation of this end point: The day of medical pregnancy termination

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Secondary

Measure	Time frame
Secondary end point(s): - The need for manual intervention type uterine revision - Need for instrumental intervention type curettage - Evaluation of uterine vacuity with ultrasound after delivery (spontaneous or manual) - Blood loss Rating: comparison of blood loss in the 2 groups - Evaluation and comparison of the incidence of postpartum hemorrhage (PPH) in the 2 groups - Comparison of pre and post hemoglobin delta IMG in the 2 groups - Comparison of fetal expulsion period - issuance in the 2 groups;Timepoint(s) of evaluation of this end point: The day of medical pregnancy termination	—

Measure

Time frame

Secondary end point(s): - The need for manual intervention type uterine revision - Need for instrumental intervention type curettage - Evaluation of uterine vacuity with ultrasound after delivery (spontaneous or manual) - Blood loss Rating: comparison of blood loss in the 2 groups - Evaluation and comparison of the incidence of postpartum hemorrhage (PPH) in the 2 groups - Comparison of pre and post hemoglobin delta IMG in the 2 groups - Comparison of fetal expulsion period - issuance in the 2 groups;Timepoint(s) of evaluation of this end point: The day of medical pregnancy termination

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Countries

France

Contacts

Public ContactREC

CHU de Bordeaux

jeremy.chateauraynaud@chu-bordeaux.fr+33557821067

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026