Postpartum HemorrhageNCT07884890
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
An observational study of Postpartum Hemorrhage and Waterbirth, run by University of Campania Luigi Vanvitelli at 2 sites in Italy.
Trial summary
During a waterbirth, blood lost in the pool between the birth of the baby and the mother's exit from the water cannot be collected or measured. At the participating centers, blood loss is measured with a graduated collector bag that is positioned only after the woman leaves the pool, for the delivery of the placenta. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postpartum Hemorrhage, Waterbirth
- What is being tested?
- Water immersion during labor and birth
- How many people
- 600 participants
- Where
- 2 sitesItaly
- Study dates
- Apr 2027to Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Low-risk women with a singleton pregnancy at term giving birth at two Italian maternity units (Caserta and Avellino) that offer water immersion in labor and waterbirth. Women are identified consecutively from the delivery ward register and classified according to their actual use of water immersion.
Who may be able to join
- Singleton pregnancy
- Cephalic presentation
- Gestational age from 37 weeks 0 days to 41 weeks 6 days
- Low-risk pregnancy, eligible for water immersion according to the protocol of the center
- Hemoglobin measured at admission in labor
- Vaginal birth; for Group C, spontaneous vaginal birth with no water immersion at any time in labor
Who cannot join
- Blood transfusion before the postpartum blood sample
- Known coagulopathy
- Cesarean delivery
- Operative vaginal delivery (Group C)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites
Azienda Ospedaliera San Giuseppe Moscati - UOC di Ginecologia e Ostetricia
Avellino, Campania
University of Campania Luigi Vanvitelli
Caserta, Campania
About this study
Official title: Measured Versus Hemoglobin-Calculated Postpartum Blood Loss After Waterbirth Compared With Land Birth: A Multicenter Observational Cohort Study
During a waterbirth, blood lost in the pool between the birth of the baby and the mother's exit from the water cannot be collected or measured. At the participating centers, blood loss is measured with a graduated collector bag that is positioned only after the woman leaves the pool, for the delivery of the placenta. The blood loss recorded after a waterbirth may therefore be lower than the true loss. The goal of this observational study, conducted in two Italian hospitals, is to learn whether measured blood loss underestimates true blood loss more after waterbirth than after birth on land. The main question it aims to answer is: Is the difference between blood loss calculated from the drop in hemoglobin and blood loss measured in the collector bag larger in women who give birth in water than in women who give birth on land without water immersion? Researchers will compare three groups of low-risk women with a singleton pregnancy at term: women who give birth in water, women who use water immersion during labor but give birth out of water, and women who do not use water immersion. No intervention is assigned by the study: each woman is classified according to what actually happened during her labor and birth. Data are taken from the clinical record and include hemoglobin at admission in labor and after birth, measured blood loss, and the timing of events in the pool and during the third stage of labor.
Read the detailed description
Design: multicenter observational cohort study conducted in two centers in Italy (Caserta and Avellino), with consecutive inclusion over 24 months. Exposure groups are defined by what actually occurred: Group A, birth in water; Group B, water immersion during labor with birth out of water (the reason for leaving the pool is recorded); Group C, no water immersion and spontaneous vaginal birth on land. All consecutive Group A and Group B births in the study period are included. Group C is formed from the delivery ward register of the same center: for each waterbirth (index case), the next three consecutive eligible births of the same parity category (nulliparous or parous) occurring within 30 days are selected; each woman can serve as a control only once, and every woman screened and skipped is logged with the reason. Eligibility of controls is decided on admission data, without knowledge of outcomes. A control with missing data is not replaced. Epidural analgesia is not an exclusion criterion; it is recorded and the analysis is repeated without those women. Blood loss assessment: measured blood loss is the volume collected in a graduated collector bag. After waterbirth the bag is positioned after the woman leaves the pool, for the delivery of the placenta. Calculated blood loss = estimated blood volume x (pre-delivery hemoglobin - postpartum hemoglobin) / pre-delivery hemoglobin, where estimated blood volume (mL) = maternal weight (kg) x 85. Pre-delivery hemoglobin is measured at admission in labor; postpartum hemoglobin is targeted at 48 hours after birth (accepted window 36 to 60 hours), at the same interval in all groups. Primary analysis: comparison between Group A and Group C of the individual difference between calculated and measured blood loss, adjusted for center, maternal age, parity, body mass index, gestational age, onset of labor, oxytocin use, duration of the first and second stage, birth weight, intravenous fluids between the two blood samples, iron therapy in pregnancy, and hours between birth and the postpartum sample. Mechanism analysis: in Group A, the difference between calculated and measured blood loss is modeled as a function of the minutes between birth and positioning of the collector bag; minutes spent in the pool after birth are used in a sensitivity analysis. A further sensitivity analysis is restricted to women sampled between 36 and 60 hours after birth. Sample size: anticipated total enrollment of 600 women over 24 months across the two centers, with three Group C controls for each Group A waterbirth; all eligible women in Group B are included. The standard deviation of the primary outcome will be re-estimated on the first 100 cases, pooled across groups and without examining the between-group difference, and the sample size updated accordingly. Prespecified secondary analyses on the same cohort: duration and management of the third stage of labor after waterbirth versus land birth; influence of postpartum sampling time and intravenous fluids on calculated blood loss; association between duration of water immersion and postpartum hemoglobin drop; reasons for leaving the pool before birth and related outcomes; perineal trauma by parity. Neonatal and infectious outcomes are reported descriptively only, because the study is not powered for rare events.
- Conditions
- Postpartum Hemorrhage, Waterbirth
- Being tested
- Water immersion during labor and birth
- Keywords
- water immersion, calculated blood loss, quantitative blood loss, third stage of labor
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water immersion during labor and birthOther
Exposure of interest, not assigned by the study. Women choose whether to use the birthing pool as part of routine care: immersion in warm water during labor only (Group B) or during labor and birth of the baby (Group A). The study only observes and records the exposure and its timing.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Waterbirth | Women who gave birth in water. All consecutive waterbirths in the study period are included. The graduated collector bag is positioned after the woman leaves the pool, for the delivery of the placenta. No intervention is assigned by the study. Receives: Other: Water immersion during labor and birth | |
| Group B: Water Immersion in Labor, Birth out of Water | Women who used water immersion during labor and gave birth out of water. All consecutive women in the study period are included, and the reason for leaving the pool is recorded. No intervention is assigned by the study. Receives: Other: Water immersion during labor and birth | |
| Group C: Land Birth Without Water Immersion | Women with no water immersion at any time in labor and a spontaneous vaginal birth on land. For each waterbirth, the next three consecutive eligible births of the same parity category within 30 days are selected from the delivery ward register. No intervention is assigned by the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between calculated and measured blood loss
Individual difference, in mL, between calculated blood loss and blood loss measured in the graduated collector bag. Calculated blood loss = maternal weight (kg) x 85 x (hemoglobin at admission in labor - postpartum hemoglobin) / hemoglobin at admission in labor. The difference is compared between Group A (waterbirth) and Group C (land birth without water immersion).
Measured: From admission in labor to the postpartum hemoglobin measurement (target 48 hours after birth, accepted window 36 to 60 hours)
Secondary outcomes (6)
Peripartum hemoglobin drop
Hemoglobin at admission in labor minus postpartum hemoglobin, in g/dL, compared between groups. The proportion of women with a drop of 2 g/dL or more is also reported.
Measured: From admission in labor to the postpartum hemoglobin measurement (target 48 hours after birth, accepted window 36 to 60 hours)
Postpartum hemorrhage of 500 mL or more, by each assessment method
Proportion of women with blood loss of 500 mL or more, reported separately for blood loss measured in the collector bag and for calculated blood loss, and compared between groups.
Measured: From birth to the postpartum hemoglobin measurement (target 48 hours after birth, accepted window 36 to 60 hours)
Postpartum hemorrhage of 1000 mL or more, by each assessment method
Proportion of women with blood loss of 1000 mL or more, reported separately for blood loss measured in the collector bag and for calculated blood loss, and compared between groups.
Measured: From birth to the postpartum hemoglobin measurement (target 48 hours after birth, accepted window 36 to 60 hours)
Red blood cell transfusion
Proportion of women receiving a red blood cell transfusion after birth, and number of units transfused, compared between groups.
Measured: From birth to hospital discharge, an average of 3 days
Intravenous iron administration
Proportion of women receiving intravenous iron after birth, compared between groups.
Measured: From birth to hospital discharge, an average of 3 days
Duration of the third stage of labor
Minutes between birth of the baby and delivery of the placenta, compared between Group A and Group C.
Measured: From birth of the baby to delivery of the placenta, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startApr 2027 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità San Giuseppe Moscati (Avellino)
- Responsible party
- Principal investigator, Marco La Verde, University of Campania Luigi Vanvitelli
- Investigators
- Marco La Verde, MD, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884890
- Sponsor's protocol ID
- WB-BLOODLOSS-2026
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies and the protection of participants' privacy.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measured Versus Hemoglobin-Calculated Postpartum Blood Loss After Waterbirth Compared With Land Birth: A Multicenter Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07884890
- Acronym / sponsor ID
- WB-BLOODLOSS-2026
- Conditions
- Postpartum Hemorrhage, Waterbirth
- Keywords
- water immersion, calculated blood loss, quantitative blood loss, third stage of labor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità San Giuseppe Moscati (Avellino)
- Study start
- Apr 2027 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 21 Oct 2026 (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.
During a waterbirth, blood lost in the pool between the birth of the baby and the mother's exit from the water cannot be collected or measured. At the participating centers, blood loss is measured with a graduated collector bag that is positioned only after the woman leaves the pool, for the delivery of the placenta. The blood loss recorded after a waterbirth may therefore be lower than the true loss. The goal of this observational study, conducted in two Italian hospitals, is to learn whether measured blood loss underestimates true blood loss more after waterbirth than after birth on land. The main question it aims to answer is: Is the difference between blood loss calculated from the drop in hemoglobin and blood loss measured in the collector bag larger in women who give birth in water than in women who give birth on land without water immersion? Researchers will compare three groups of low-risk women with a singleton pregnancy at term: women who give birth in water, women who use water immersion during labor but give birth out of water, and women who do not use water immersion. No intervention is assigned by the study: each woman is classified according to what actually happened during her labor and birth. Data are taken from the clinical record and include hemoglobin at admission in labor and after birth, measured blood loss, and the timing of events in the pool and during the third stage of labor.
Detailed description
Design: multicenter observational cohort study conducted in two centers in Italy (Caserta and Avellino), with consecutive inclusion over 24 months. Exposure groups are defined by what actually occurred: Group A, birth in water; Group B, water immersion during labor with birth out of water (the reason for leaving the pool is recorded); Group C, no water immersion and spontaneous vaginal birth on land. All consecutive Group A and Group B births in the study period are included. Group C is formed from the delivery ward register of the same center: for each waterbirth (index case), the next three consecutive eligible births of the same parity category (nulliparous or parous) occurring within 30 days are selected; each woman can serve as a control only once, and every woman screened and skipped is logged with the reason. Eligibility of controls is decided on admission data, without knowledge of outcomes. A control with missing data is not replaced. Epidural analgesia is not an exclusion criterion; it is recorded and the analysis is repeated without those women. Blood loss assessment: measured blood loss is the volume collected in a graduated collector bag. After waterbirth the bag is positioned after the woman leaves the pool, for the delivery of the placenta. Calculated blood loss = estimated blood volume x (pre-delivery hemoglobin - postpartum hemoglobin) / pre-delivery hemoglobin, where estimated blood volume (mL) = maternal weight (kg) x 85. Pre-delivery hemoglobin is measured at admission in labor; postpartum hemoglobin is targeted at 48 hours after birth (accepted window 36 to 60 hours), at the same interval in all groups. Primary analysis: comparison between Group A and Group C of the individual difference between calculated and measured blood loss, adjusted for center, maternal age, parity, body mass index, gestational age, onset of labor, oxytocin use, duration of the first and second stage, birth weight, intravenous fluids between the two blood samples, iron therapy in pregnancy, and hours between birth and the postpartum sample. Mechanism analysis: in Group A, the difference between calculated and measured blood loss is modeled as a function of the minutes between birth and positioning of the collector bag; minutes spent in the pool after birth are used in a sensitivity analysis. A further sensitivity analysis is restricted to women sampled between 36 and 60 hours after birth. Sample size: anticipated total enrollment of 600 women over 24 months across the two centers, with three Group C controls for each Group A waterbirth; all eligible women in Group B are included. The standard deviation of the primary outcome will be re-estimated on the first 100 cases, pooled across groups and without examining the between-group difference, and the sample size updated accordingly. Prespecified secondary analyses on the same cohort: duration and management of the third stage of labor after waterbirth versus land birth; influence of postpartum sampling time and intravenous fluids on calculated blood loss; association between duration of water immersion and postpartum hemoglobin drop; reasons for leaving the pool before birth and related outcomes; perineal trauma by parity. Neonatal and infectious outcomes are reported descriptively only, because the study is not powered for rare events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Waterbirth | – | Other: Water immersion during labor and birthWomen who gave birth in water. All consecutive waterbirths in the study period are included. The graduated collector bag is positioned after the woman leaves the pool, for the delivery of the placenta. No intervention is assigned by the study. |
| Group B: Water Immersion in Labor, Birth out of Water | – | Other: Water immersion during labor and birthWomen who used water immersion during labor and gave birth out of water. All consecutive women in the study period are included, and the reason for leaving the pool is recorded. No intervention is assigned by the study. |
| Group C: Land Birth Without Water Immersion | – | –Women with no water immersion at any time in labor and a spontaneous vaginal birth on land. For each waterbirth, the next three consecutive eligible births of the same parity category within 30 days are selected from the delivery ward register. No intervention is assigned by the study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Low-risk women with a singleton pregnancy at term giving birth at two Italian maternity units (Caserta and Avellino) that offer water immersion in labor and waterbirth. Women are identified consecutively from the delivery ward register and classified according to their actual use of water immersion.
Key inclusion criteria (6 listed)
- Singleton pregnancy
- Cephalic presentation
- Gestational age from 37 weeks 0 days to 41 weeks 6 days
- Low-risk pregnancy, eligible for water immersion according to the protocol of the center
- Hemoglobin measured at admission in labor
Key exclusion criteria (4 listed)
- Blood transfusion before the postpartum blood sample
- Known coagulopathy
- Cesarean delivery
- Operative vaginal delivery (Group C)
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 |
|---|---|---|
| Water immersion during labor and birthExposure of interest, not assigned by the study. Women choose whether to use the birthing pool as part of routine care: immersion in warm water during labor only (Group B) or during labor and birth of the baby (Group A). The study only observes and records the exposure and its timing. | Other | Group A: Waterbirth, Group B: Water Immersion in Labor, Birth out of Water |
Primary outcome
Difference between calculated and measured blood loss
Time frame: From admission in labor to the postpartum hemoglobin measurement (target 48 hours after birth, accepted window 36 to 60 hours)
Individual difference, in mL, between calculated blood loss and blood loss measured in the graduated collector bag. Calculated blood loss = maternal weight (kg) x 85 x (hemoglobin at admission in labor - postpartum hemoglobin) / hemoglobin at admission in labor. The difference is compared between Group A (waterbirth) and Group C (land birth without water immersion).
6 secondary outcomes
Peripartum hemoglobin drop
Time frame: From admission in labor to the postpartum hemoglobin measurement (target 48 hours after birth, accepted window 36 to 60 hours)
Postpartum hemorrhage of 500 mL or more, by each assessment method
Time frame: From birth to the postpartum hemoglobin measurement (target 48 hours after birth, accepted window 36 to 60 hours)
Postpartum hemorrhage of 1000 mL or more, by each assessment method
Time frame: From birth to the postpartum hemoglobin measurement (target 48 hours after birth, accepted window 36 to 60 hours)
Red blood cell transfusion
Time frame: From birth to hospital discharge, an average of 3 days
Intravenous iron administration
Time frame: From birth to hospital discharge, an average of 3 days
Duration of the third stage of labor
Time frame: From birth of the baby to delivery of the placenta, up to 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies and the protection of participants' privacy.
Related trials for Postpartum Hemorrhage
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Prevention of Postpartum Hemorrhage With Tranexamic Acid
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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.
Marco La Verde, MD principal investigator
University of Campania Luigi Vanvitelli
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage and Waterbirth, run by University of Campania Luigi Vanvitelli at 2 sites in Italy.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco La Verde, MD (+390815665600, marco.laverde@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between calculated and measured blood loss (time frame: From admission in labor to the postpartum hemoglobin measurement (target 48 hours after birth, accepted window 36 to 60 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2026.