Prolonged Second Stage of LaborVaDe-4NCT05612321
Vacuum Delivery in All-fours Position vs Traditional Position
A study testing Vacuum application in people with Prolonged Second Stage of Labor and Prolonged Second Stage of Labor Due to Poor Maternal Effort, run by Ospedale degli Infermi di Biella.
Trial summary
The aim of the study is to investigate the safety, clinical efficacy and the maternal/neonatal outcomes of vacuum application in all-fours position compared with supine traditional position, in women undergoing vacuum-assisted delivery during the second stage of labor. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Prolonged Second Stage of Labor, Prolonged Second Stage of Labor Due to Poor Maternal Effort
- What is being tested?
- Vacuum application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women
- singleton
- cephalic presentation
- term pregnancy
- second stage of labor
- failure to progress
- maternal weariness
- need for operative vaginal delivery by vacuum extraction
Who cannot join
- enrollment refusal
- absence of consent
- contraindication to operative vaginal delivery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: All-fours Position vs Traditional Position in Women Undergoing Vacuum-assisted Delivery: the VaDe-4 Randomized Controlled Trial
The aim of the study is to investigate the safety, clinical efficacy and the maternal/neonatal outcomes of vacuum application in all-fours position compared with supine traditional position, in women undergoing vacuum-assisted delivery during the second stage of labor.
The main question it aims to answer are:
Read more
- Does the rate of failure of vacuum delivery, measured as number of cup detachments and the need of emergency caesarean section is lower if vacuum delivery is performed on a woman in all-fours position?
- Do maternal and fetal outcomes are better in case vacuum delivery in all-fours position?
Participants will be randomly enrolled at the admission in two different groups, Control and Experimental Group, and in case of need for vacuum-assisted vaginal delivery; women belonging to Control Group will undergo vacuum-assisted delivery in traditional supine position, while women in Experimental Group will experience vacuum application in all-fours position.
Researchers will compare the Group A, composed by women who undergo vacuum-delivery in traditional supine position, with Group B, in which women are in "all-fours" position, to see if hands-and-knees position provides better outcomes.
Read the detailed description
In the last decades, a decrease in operative vaginal delivery (OVD) rates occurred, resulting in increase of caesarean sections (CS) during the second stage of labor. This attitude reflects Clinicians' worries about operative vaginal delivery morbidity, together with a consequent loss of clinical skills in this practice. However, vacuum delivery - when correctly performed - requires less analgesia and gives women higher chances to have a spontaneous vaginal birth in the following pregnancy, whereas emergency C-section is burdened by different maternal and fetal complications. Moreover, should fetal compromise be occurring, time to start the procedure is longer for CS than for vacuum application. Due to the whole of these reasons, operative vaginal delivery is included in the main international guidelines as the best option for the mother and baby, in case of arrest/delay of fetal head descent during second stage of labor, with fetal head at mid/low-pelvic station.
Although women in labor are usually asked to choose the position they prefer and to change position frequently to facilitate the alignment of the fetal head with the birth canal, the vacuum cup is usually applied to a woman lying in the "traditional" gynecological supine position.
Despite several demonstrated advantages, fewer women choose non-recumbent positions, and among them, the so-called "all-fours position" (or "hands-and-knees") which has the higher evidence of benefit. In all-fours, the woman is on her knees, leaning on her hands, with abdomen suspended and hips at right angles to the floor or bed. As demonstrated in different studies, the main advantage given by this posture is the increase of all posterior diameters of the pelvis. This finding implies not only an easier descent of the fetal head, helped by gravity, but also a wider space where fetal head could rotate in case of occiput posterior position, preventing fetal malposition. Additionally, this position lets the sacrum to have more posterior mobility (contra-nutation movement) furtherly widening the outlet no more constricted by the standing surface and reducing sacral pain due to bed-contact. Moreover, as the burden of trunk's weight on the sacrum is decreased in all-fours, women consider the hands-and-knees position a pain-relieving postural choice, especially during the first stage of labor. Regarding maternal outcomes, a recent large randomized controlled trial, involving 1400 women, demonstrated a lower incidence of second-degree perineal lacerations, episiotomy and perineal swelling in hands-and-knees position, and a lower risk of emergency CS, compared to other birth positions.
In the all-fours position, the vaginal space between the fetal head and the vaginal ostium is not influenced by body weight, resulting wider, visible, and easily explorable. Moreover, the risk of vacuum cup sliding is lower because the upward traction is allotted a wider space.
The widening of birth canal obtained with this technique has several, beneficial implications. First, the risk of vaginal tear is lower, since there is no redundant vaginal tissue that could be trapped inside the cup. Second, a wider space allows to constantly maintain the vacuum wire perpendicular to the cup, thus determining a lower risk of detachment, subsequent fetal scalp damage and cephalohematoma (e.g., in presence of caput succedaneum).
Also, this position allows a better propulsive pushing, thanks to a more efficient Valsalva maneuver, thus enabling the Clinician not to exert excessive traction on the fetal head.
Since OVD has a known increased risk of shoulder dystocia, adopting the all-fours position should be beneficial in preventing this fearsome complication, consistent with the point that the hands-and-knees posture is required to perform the Gaskin maneuver, a rescue procedure that easily releases the trapped shoulder by taking advantage of the greater posterior pelvic space in this position.
A potential disadvantage might be the inability of the woman to keep this position for longer than 10-15 minutes. Although OVD duration is routinely much shorter, it is of course mandatory that the timing of OVD performance be carefully monitored.
The investigators recently suggested the implementation of all-fours position in case of operative vaginal delivery and we published a video-simulation of vacuum application on a mannequin. At this time, no other prospective study so far assessed a putative effectiveness of an alternative positioning strategy during OVD for women with arrest of fetal head progression during the second stage of labor.
- Conditions
- Prolonged Second Stage of Labor, Prolonged Second Stage of Labor Due to Poor Maternal Effort
- Being tested
- Vacuum application
- Keywords
- Vacuum-assisted vaginal delivery, All-fours position, Arrest of descent, Operative vaginal delivery
- Medical subject headings
- Cephalopelvic Disproportion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum applicationDevice
vacuum-assisted delivery
| Study group | Role | What they receive |
|---|---|---|
| Traditional supine position | Active comparator | Participants enrolled in the Control Group undergo vacuum-assisted delivery in traditional supine position (supine with 90 degrees bended legs on footrests) Receives: Device: Vacuum application |
| All-fours position | Experimental | Participants enrolled in Experimental Group experience vacuum application in all-fours position. Receives: Device: Vacuum application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vacuum detachments
Vacuum detachments (Yes/No)
Measured: Day 0
Rate of Emergency C-Section
Emergency C-section (Yes/No)
Measured: Day 0
Secondary outcomes (17)
Perineal tears
Perineal tears (1st-3rd grade) (Yes/No and Grade: 1st/2nd/3rd grade)
Measured: Day 1
Obstetric anal sphincter injuries (OASIS)
Obstetric anal sphincter injuries (OASIS, 4th grade) (Yes/No)
Measured: Day 1
Episiotomy
Episiotomy (Yes/No)
Measured: Day 1
Blood loss
Maternal blood loss (ml)
Measured: Day 1
Postpartum haemorrhage
Postpartum haemorrhage defined as a blood loss of >1000milliliters (Yes/No)
Measured: Day 1
Necessity of Blood Transfusions
Blood Transfusions (Yes/no and n. bagged blood infused)
Measured: Day 3
Maternal infections
Maternal infections (endometritis, sepsis, hyperpyrexia) (Yes/No)
Measured: Day 3
Length of Hospital Stay
Length of Hospital Stay (n. of days of hospitalization)
Measured: Day 30
Patient Satisfaction
Short-form patient satisfaction questionnaire (PSQ-18) (18 and 90 are the minimum and maximum values, and higher scores mean a higher patient satisfaction).
Measured: Day 30
APGAR score
APGAR score at 1 and 5 minutes (0-10)
Measured: Day 0
Neonatal acidosis
pH < 7.10 at birth (Yes/No)
Measured: Day 0
Neonatal hypoglycaemia
Neonatal Serum Glucose < 45 mg/dL (< 2.5 mmol/L) (Yes/No)
Measured: Day 1
Neonatal cephalohematoma
Neonatal cephalohematoma (Yes/No)
Measured: Day 1
Neonatal scalp damages
Neonatal scalp damages (Yes/No)
Measured: Day 1
Shoulder Dystocia
Shoulder Dystocia (Yes/No)
Measured: Day 0
Admission to Neonatal Intensive Care Unit (NICU)
Admission to Neonatal Intensive Care Unit (NICU) (Yes/No)
Measured: Day 30
Need for Oxygen Supplementation
Neonatal need for supplementary oxygen (yes/no) and days of use (days)
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Prolonged Second Stage of LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, prospective, randomized open trial
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale degli Infermi di Biella
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bianca Masturzo, Ospedale degli Infermi di Biella
- Investigators
- Bianca Masturzo, Md, PhD, Principal investigator, Ospedale degli Infermi di Biella
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612321
- Sponsor's protocol ID
- VaDe-4/2022
- Acronym
- VaDe-4
- Status last verified
- Nov 2022
- First submitted
- 19 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All collected IPD
Publications
Merriam AA, Ananth CV, Wright JD, Siddiq Z, D'Alton ME, Friedman AM. Trends in operative vaginal delivery, 2005-2013: a population-based study. BJOG. 2017 Aug;124(9):1365-1372. doi: 10.1111/1471-0528.14553. Epub 2017 Feb 25.
PubMed 28236337Spencer C, Murphy D, Bewley S. Caesarean delivery in the second stage of labour. BMJ. 2006 Sep 23;333(7569):613-4. doi: 10.1136/bmj.38971.466979.DE. No abstract available.
PubMed 16990297Guo C, Ma W, Fan D, Ma Y, Liu L. Non spontaneous vaginal delivery was associated with lower probability of subsequent fertility. Eur J Obstet Gynecol Reprod Biol. 2020 May;248:30-36. doi: 10.1016/j.ejogrb.2020.03.009. Epub 2020 Mar 7.
PubMed 32172023Operative Vaginal Birth: ACOG Practice Bulletin, Number 219. Obstet Gynecol. 2020 Apr;135(4):e149-e159. doi: 10.1097/AOG.0000000000003764.
PubMed 32217976RANZCOG. The Women's Health Committee. The Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Instrumental vaginal birth; March 2016.
Hobson S, Cassell K, Windrim R, Cargill Y. No. 381-Assisted Vaginal Birth. J Obstet Gynaecol Can. 2019 Jun;41(6):870-882. doi: 10.1016/j.jogc.2018.10.020.
PubMed 31126436Murphy DJ, Strachan BK, Bahl R; Royal College of Obstetricians and Gynaecologists. Assisted Vaginal Birth: Green-top Guideline No. 26. BJOG. 2020 Aug;127(9):e70-e112. doi: 10.1111/1471-0528.16092. Epub 2020 Apr 28. No abstract available.
PubMed 32346983Stremler R, Hodnett E, Petryshen P, Stevens B, Weston J, Willan AR. Randomized controlled trial of hands-and-knees positioning for occipitoposterior position in labor. Birth. 2005 Dec;32(4):243-51. doi: 10.1111/j.0730-7659.2005.00382.x.
PubMed 16336365Siccardi M, Valle C, Di Matteo F. Dynamic External Pelvimetry Test in Third Trimester Pregnant Women: Shifting Positions Affect Pelvic Biomechanics and Create More Room in Obstetric Diameters. Cureus. 2021 Mar 1;13(3):e13631. doi: 10.7759/cureus.13631.
PubMed 33816030Michel SC, Rake A, Treiber K, Seifert B, Chaoui R, Huch R, Marincek B, Kubik-Huch RA. MR obstetric pelvimetry: effect of birthing position on pelvic bony dimensions. AJR Am J Roentgenol. 2002 Oct;179(4):1063-7. doi: 10.2214/ajr.179.4.1791063.
PubMed 12239066Hemmerich A, Bandrowska T, Dumas GA. The effects of squatting while pregnant on pelvic dimensions: A computational simulation to understand childbirth. J Biomech. 2019 Apr 18;87:64-74. doi: 10.1016/j.jbiomech.2019.02.017. Epub 2019 Feb 27.
PubMed 30851977Zhang H, Huang S, Guo X, Zhao N, Lu Y, Chen M, Li Y, Wu J, Huang L, Ma F, Yang Y, Zhang X, Zhou X, Guo R, Cai W. A randomised controlled trial in comparing maternal and neonatal outcomes between hands-and-knees delivery position and supine position in China. Midwifery. 2017 Jul;50:117-124. doi: 10.1016/j.midw.2017.03.022. Epub 2017 Mar 31.
PubMed 28414983Bothou A, Apostolidi DM, Tsikouras P, Iatrakis G, Sarella A, Iatrakis D, Peitsidis P, Gerente A, Anthoulaki X, Nikolettos N, Zervoudis S. Overview of techniques to manage shoulder dystocia during vaginal birth. Eur J Midwifery. 2021 Oct 20;5:48. doi: 10.18332/ejm/142097. eCollection 2021.
PubMed 34723155Masturzo B, Delogu G, Germano C, Ghi T, Rizzo G, Puppo A, Attini R, Revelli A, Manzoni P. Vacuum delivery in all-fours position: is it a valuable, brand-new option? Am J Obstet Gynecol MFM. 2022 Nov;4(6):100691. doi: 10.1016/j.ajogmf.2022.100691. Epub 2022 Jul 16.
PubMed 35843544
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All-fours Position vs Traditional Position in Women Undergoing Vacuum-assisted Delivery: the VaDe-4 Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05612321
- Acronym / sponsor ID
- VaDe-4 / VaDe-4/2022
- Conditions
- Prolonged Second Stage of Labor, Prolonged Second Stage of Labor Due to Poor Maternal Effort
- Keywords
- Vacuum-assisted vaginal delivery, All-fours position, Arrest of descent, Operative vaginal delivery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ospedale degli Infermi di BiellaUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate the safety, clinical efficacy and the maternal/neonatal outcomes of vacuum application in all-fours position compared with supine traditional position, in women undergoing vacuum-assisted delivery during the second stage of labor.
The main question it aims to answer are:
- Does the rate of failure of vacuum delivery, measured as number of cup detachments and the need of emergency caesarean section is lower if vacuum delivery is performed on a woman in all-fours position?
- Do maternal and fetal outcomes are better in case vacuum delivery in all-fours position?
Participants will be randomly enrolled at the admission in two different groups, Control and Experimental Group, and in case of need for vacuum-assisted vaginal delivery; women belonging to Control Group will undergo vacuum-assisted delivery in traditional supine position, while women in Experimental Group will experience vacuum application in all-fours position.
Researchers will compare the Group A, composed by women who undergo vacuum-delivery in traditional supine position, with Group B, in which women are in "all-fours" position, to see if hands-and-knees position provides better outcomes.
Detailed description
In the last decades, a decrease in operative vaginal delivery (OVD) rates occurred, resulting in increase of caesarean sections (CS) during the second stage of labor. This attitude reflects Clinicians' worries about operative vaginal delivery morbidity, together with a consequent loss of clinical skills in this practice. However, vacuum delivery - when correctly performed - requires less analgesia and gives women higher chances to have a spontaneous vaginal birth in the following pregnancy, whereas emergency C-section is burdened by different maternal and fetal complications. Moreover, should fetal compromise be occurring, time to start the procedure is longer for CS than for vacuum application. Due to the whole of these reasons, operative vaginal delivery is included in the main international guidelines as the best option for the mother and baby, in case of arrest/delay of fetal head descent during second stage of labor, with fetal head at mid/low-pelvic station.
Although women in labor are usually asked to choose the position they prefer and to change position frequently to facilitate the alignment of the fetal head with the birth canal, the vacuum cup is usually applied to a woman lying in the "traditional" gynecological supine position.
Despite several demonstrated advantages, fewer women choose non-recumbent positions, and among them, the so-called "all-fours position" (or "hands-and-knees") which has the higher evidence of benefit. In all-fours, the woman is on her knees, leaning on her hands, with abdomen suspended and hips at right angles to the floor or bed. As demonstrated in different studies, the main advantage given by this posture is the increase of all posterior diameters of the pelvis. This finding implies not only an easier descent of the fetal head, helped by gravity, but also a wider space where fetal head could rotate in case of occiput posterior position, preventing fetal malposition. Additionally, this position lets the sacrum to have more posterior mobility (contra-nutation movement) furtherly widening the outlet no more constricted by the standing surface and reducing sacral pain due to bed-contact. Moreover, as the burden of trunk's weight on the sacrum is decreased in all-fours, women consider the hands-and-knees position a pain-relieving postural choice, especially during the first stage of labor. Regarding maternal outcomes, a recent large randomized controlled trial, involving 1400 women, demonstrated a lower incidence of second-degree perineal lacerations, episiotomy and perineal swelling in hands-and-knees position, and a lower risk of emergency CS, compared to other birth positions.
In the all-fours position, the vaginal space between the fetal head and the vaginal ostium is not influenced by body weight, resulting wider, visible, and easily explorable. Moreover, the risk of vacuum cup sliding is lower because the upward traction is allotted a wider space.
The widening of birth canal obtained with this technique has several, beneficial implications. First, the risk of vaginal tear is lower, since there is no redundant vaginal tissue that could be trapped inside the cup. Second, a wider space allows to constantly maintain the vacuum wire perpendicular to the cup, thus determining a lower risk of detachment, subsequent fetal scalp damage and cephalohematoma (e.g., in presence of caput succedaneum).
Also, this position allows a better propulsive pushing, thanks to a more efficient Valsalva maneuver, thus enabling the Clinician not to exert excessive traction on the fetal head.
Since OVD has a known increased risk of shoulder dystocia, adopting the all-fours position should be beneficial in preventing this fearsome complication, consistent with the point that the hands-and-knees posture is required to perform the Gaskin maneuver, a rescue procedure that easily releases the trapped shoulder by taking advantage of the greater posterior pelvic space in this position.
A potential disadvantage might be the inability of the woman to keep this position for longer than 10-15 minutes. Although OVD duration is routinely much shorter, it is of course mandatory that the timing of OVD performance be carefully monitored.
The investigators recently suggested the implementation of all-fours position in case of operative vaginal delivery and we published a video-simulation of vacuum application on a mannequin. At this time, no other prospective study so far assessed a putative effectiveness of an alternative positioning strategy during OVD for women with arrest of fetal head progression during the second stage of labor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre, prospective, randomized open trial
| Arm | Type | Receives |
|---|---|---|
| Traditional supine position | Active comparator | Device: Vacuum applicationParticipants enrolled in the Control Group undergo vacuum-assisted delivery in traditional supine position (supine with 90 degrees bended legs on footrests) |
| All-fours position | Experimental | Device: Vacuum applicationParticipants enrolled in Experimental Group experience vacuum application in all-fours position. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- women
- singleton
- cephalic presentation
- term pregnancy
- second stage of labor
Key exclusion criteria (3 listed)
- enrollment refusal
- absence of consent
- contraindication to operative vaginal delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vacuum applicationvacuum-assisted delivery | Device | All-fours position, Traditional supine position |
Primary outcome
Vacuum detachments
Time frame: Day 0
Vacuum detachments (Yes/No)
Rate of Emergency C-Section
Time frame: Day 0
Emergency C-section (Yes/No)
17 secondary outcomes
Perineal tears
Time frame: Day 1
Obstetric anal sphincter injuries (OASIS)
Time frame: Day 1
Episiotomy
Time frame: Day 1
Blood loss
Time frame: Day 1
Postpartum haemorrhage
Time frame: Day 1
Necessity of Blood Transfusions
Time frame: Day 3
Maternal infections
Time frame: Day 3
Length of Hospital Stay
Time frame: Day 30
Patient Satisfaction
Time frame: Day 30
APGAR score
Time frame: Day 0
Neonatal acidosis
Time frame: Day 0
Neonatal hypoglycaemia
Time frame: Day 1
Neonatal cephalohematoma
Time frame: Day 1
Neonatal scalp damages
Time frame: Day 1
Shoulder Dystocia
Time frame: Day 0
Admission to Neonatal Intensive Care Unit (NICU)
Time frame: Day 30
Need for Oxygen Supplementation
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Results publication: PubMed 28236337Merriam AA, Ananth CV, Wright JD, Siddiq Z, D'Alton ME, Friedman AM. Trends in operative vaginal delivery, 2005-2013: a population-based study. BJOG. 2017 Aug;124(9):1365-1372. doi: 10.1111/1471-0528.14553. Epub 2017 Feb 25.
- Results publication: PubMed 16990297Spencer C, Murphy D, Bewley S. Caesarean delivery in the second stage of labour. BMJ. 2006 Sep 23;333(7569):613-4. doi: 10.1136/bmj.38971.466979.DE. No abstract available.
- Results publication: PubMed 32172023Guo C, Ma W, Fan D, Ma Y, Liu L. Non spontaneous vaginal delivery was associated with lower probability of subsequent fertility. Eur J Obstet Gynecol Reprod Biol. 2020 May;248:30-36. doi: 10.1016/j.ejogrb.2020.03.009. Epub 2020 Mar 7.
- Results publication: PubMed 32217976Operative Vaginal Birth: ACOG Practice Bulletin, Number 219. Obstet Gynecol. 2020 Apr;135(4):e149-e159. doi: 10.1097/AOG.0000000000003764.
- Results publicationRANZCOG. The Women's Health Committee. The Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Instrumental vaginal birth; March 2016.
- Results publication: PubMed 31126436Hobson S, Cassell K, Windrim R, Cargill Y. No. 381-Assisted Vaginal Birth. J Obstet Gynaecol Can. 2019 Jun;41(6):870-882. doi: 10.1016/j.jogc.2018.10.020.
- Results publication: PubMed 32346983Murphy DJ, Strachan BK, Bahl R; Royal College of Obstetricians and Gynaecologists. Assisted Vaginal Birth: Green-top Guideline No. 26. BJOG. 2020 Aug;127(9):e70-e112. doi: 10.1111/1471-0528.16092. Epub 2020 Apr 28. No abstract available.
- Results publication: PubMed 16336365Stremler R, Hodnett E, Petryshen P, Stevens B, Weston J, Willan AR. Randomized controlled trial of hands-and-knees positioning for occipitoposterior position in labor. Birth. 2005 Dec;32(4):243-51. doi: 10.1111/j.0730-7659.2005.00382.x.
- Results publication: PubMed 33816030Siccardi M, Valle C, Di Matteo F. Dynamic External Pelvimetry Test in Third Trimester Pregnant Women: Shifting Positions Affect Pelvic Biomechanics and Create More Room in Obstetric Diameters. Cureus. 2021 Mar 1;13(3):e13631. doi: 10.7759/cureus.13631.
- Results publication: PubMed 12239066Michel SC, Rake A, Treiber K, Seifert B, Chaoui R, Huch R, Marincek B, Kubik-Huch RA. MR obstetric pelvimetry: effect of birthing position on pelvic bony dimensions. AJR Am J Roentgenol. 2002 Oct;179(4):1063-7. doi: 10.2214/ajr.179.4.1791063.
- Results publication: PubMed 30851977Hemmerich A, Bandrowska T, Dumas GA. The effects of squatting while pregnant on pelvic dimensions: A computational simulation to understand childbirth. J Biomech. 2019 Apr 18;87:64-74. doi: 10.1016/j.jbiomech.2019.02.017. Epub 2019 Feb 27.
- Results publication: PubMed 28414983Zhang H, Huang S, Guo X, Zhao N, Lu Y, Chen M, Li Y, Wu J, Huang L, Ma F, Yang Y, Zhang X, Zhou X, Guo R, Cai W. A randomised controlled trial in comparing maternal and neonatal outcomes between hands-and-knees delivery position and supine position in China. Midwifery. 2017 Jul;50:117-124. doi: 10.1016/j.midw.2017.03.022. Epub 2017 Mar 31.
- Individual participant dataSharing planned: Yes. All collected IPD
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Prolonged Second Stage of Labor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bianca Masturzo, Md, PhD principal investigator
Ospedale degli Infermi di Biella
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum application in people with Prolonged Second Stage of Labor and Prolonged Second Stage of Labor Due to Poor Maternal Effort, run by Ospedale degli Infermi di Biella.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bianca Masturzo, MD PhD (+39 01515157001, bianca.masturzo@aslbi.piemonte.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vacuum detachments (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05612321, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.