---
title: R. I. S. POS. T. A
nct_id: NCT01991665
overall_status: UNKNOWN
phase: NA
sponsor: University of Bologna
study_type: INTERVENTIONAL
primary_condition: Vacuum Extraction; Failure, Affecting Fetus or Newborn
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01991665.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01991665"
ct_last_update_post_date: 2017-05-03
last_seen_at: "2026-05-12T07:18:04.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# R. I. S. POS. T. A

**Official Title:** Randomised Italian Sonography for Occiput POSition Trial Ante Vacuum

**NCT ID:** [NCT01991665](https://clinicaltrials.gov/study/NCT01991665)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 1400
- **Lead Sponsor:** University of Bologna
- **Conditions:** Vacuum Extraction; Failure, Affecting Fetus or Newborn, Persistent Occiput Posterior Position During Labor, Complication of Delivery
- **Start Date:** 2014-01
- **Completion Date:** 2018-04
- **CT.gov Last Update:** 2017-05-03

## Brief Summary

A failed operative vaginal delivery is associated with increased risk of maternal and perinatal complications. It is very important the determination of the fetal head position prior to instrumental delivery.

Generally,diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. There is a paucity of studies on the accuracy of digital examination but the general consensus is that reproducibility is low and diagnostic uncertainty remains high even for operators with much experience.

As the traditional clinical evaluation has many limitations, a new tool capable of increasing diagnostic objectivity and accuracy would be of great interest.

The aim of our study was to evaluate, in a prospective study, if the complementary use of ultrasound scan, to diagnose the fetal head position prior to instrumental delivery, may play a role in labor outcome.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 50 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* women with singleton cephalic pregnancies at term (≥37 weeks' gestation), who require an instrumental delivery

Exclusion Criteria:

* under 18 years of age
* women with contraindications for vacuum delivery
* women with sonography evaluation of fetal head position before randomization
* fetal head station \> +3
* discretion of the responsible obstetrician in cases where there is urgency due to suspected fetal compromise("fetal distress")
```

## Arms

- **Group A** (OTHER) — Digital examination before instrumental delivery to determine fetal head station and position
- **Group B** (OTHER) — Digital examination before instrumental delivery to determine fetal head station and position + sonography evaluation of fetal head position

## Interventions

- **Digital examination** (OTHER)
- **Sonography evaluation** (OTHER)

## Primary Outcomes

- **failure rate of vacuum extraction in each of the two groups of patients included in the study (number of cesarean deliveries).** _(time frame: 2 years)_

## Secondary Outcomes

- **Incidence of: neonatal trauma (cephalhaematoma, retinal haemorrhage, facial nerve palsy, brachial plexus injury and fractures), low Apgar scores, fetal acidosis or admission to the neonatal unit, shoulder dystocia** _(time frame: 2 years)_
- **Incidence of: primary postpartum haemorrhage, third and fourth degree perineal tears** _(time frame: 2 years)_

## Locations (1)

- Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi University Hospital, University of Bologna, Bologna, Emilia-Romagna, Italy — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of obstetrics and gynecology, sant'orsola-malpighi university hospital, university of bologna|bologna|emilia-romagna|italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01991665.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01991665*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*