Missed AbortionNCT06469203
Oxytocin Effectiveness in First Trimester Dilatation and Curettage
A study testing Oxytocin and Sodium Chloride 0.9% Inj in people with Missed Abortion, run by Assuta Ashdod Hospital.
Trial summary
The aim of this study is to investigate the impact of oxytocin on perioperative blood loss during the D\&C procedure, as well as to assess early and late complications associated with it's use. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Missed Abortion
- What is being tested?
- Oxytocin and Sodium Chloride 0.9% Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to Jun 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted to the OBGYN Assuta Ashdod Hospital for elective surgical termination of pregnancy due to missed miscarriages in the first trimester, with gestational age range of 6.0 to 11.6 weeks.
- Patients aged 18 years and older who are capable to provide informed consent.
Who cannot join
- individual intolerance to oxytocin
- mullerian anomalies
- Fibroid uterus
- thrombophilia or coagulation disorders
- cardiovascular disease
About this study
The aim of this study is to investigate the impact of oxytocin on perioperative blood loss during the D\&C procedure, as well as to assess early and late complications associated with it's use.
Read the detailed description
Study Design
This study is a prospective randomized placebo-controlled double-blind trial. Women undergoing dilation and curettage, who meet the eligibility criteria for the study, will be divided into two groups. They will receive the assigned medication at the beginning of the procedure, after cervical dilation but before using suction curettage.
Group 1: Participants will receive 100 ml of saline alone. Group 2: Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.
The medication bags will be prepared by the Assuta Ashdod University Hospital Pharmacy, coded with serial numbers, and randomized using computerized software. Both the investigators and patients will remain unaware of the composition of the distension medium to ensure blinding.
A total of 160 patients will be included in the sample size resulting in a net total of 80 patients per group as described below. Patients who choose to withdraw from the study will still be analyzed as intention-to-treat patients.
Inclusion Criteria:
All patients admitted to the OBGYN Assuta Ashdod Hospital for elective surgical termination of pregnancy due to missed miscarriages in the first trimester, with gestational age range of 6.0 to 11.6 weeks.
Patients aged 18 years and older who are capable to provide informed consent.
Exclusion criteria
- individual intolerance to oxytocin
- mullerian anomalies
- Fibroid uterus
- thrombophilia or coagulation disorders
- cardiovascular disease
Primary outcome
Perioperative Blood Loss Assessment:
We will assess perioperative blood loss by:
- Measuring the content collected in the vacuum apparatus after the procedure.
- Recording hemoglobin and hematocrit levels prior to the procedure.
- Measuring hemoglobin and hematocrit levels immediately after the procedure.
- Monitoring hemoglobin and hematocrit levels two weeks post-procedure.
Secondary outcomes
-perioperative complications according to the Dindo-Clavien scale
- Conditions
- Missed Abortion
- Being tested
- Oxytocin, Sodium Chloride 0.9% Inj
- Keywords
- missed abortion, vaginal bleeding, dilation and curretage, pregnancy termination, oxytocin
- Medical subject headings
- Abortion, Missed, Uterine Hemorrhage, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Women undergoing dilation and curettage, who meet the eligibility criteria for the study, will be divided into two groups. They will receive the assigned medication at the beginning of the procedure, after cervical dilation but before using suction curettage.
Group 1: Participants will receive 100 ml of saline alone. Group 2: Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.
Sodium Chloride 0.9% InjDrug
Women undergoing dilation and curettage, who meet the eligibility criteria for the study, will be divided into two groups. They will receive the assigned medication at the beginning of the procedure, after cervical dilation but before using suction curettage.
Group 1: Participants will receive 100 ml of saline alone. Group 2: Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive 100 ml of saline alone. Receives: Drug: Sodium Chloride 0.9% Inj |
| Oxytocin | Experimental | Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline. Receives: Drug: Oxytocin; Drug: Sodium Chloride 0.9% Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Blood Loss Assessment
We will assess perioperative blood loss by:
- Measuring the content collected in the vacuum apparatus after the procedure.
- Recording hemoglobin and hematocrit levels prior to the procedure.
- Measuring hemoglobin and hematocrit levels immediately after the procedure.
- Monitoring hemoglobin and hematocrit levels two weeks post-procedure.
Measured: 14 days
Secondary outcomes (1)
perioperative complications according to the Dindo-Clavien scale
perioperative complications according to the Dindo-Clavien scale
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missed AbortionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women undergoing dilation and curettage, who meet the eligibility criteria for the study, will be divided into two groups. They will receive the assigned medication at the beginning of the procedure, after cervical dilation but before using suction curettage. Group 1: Participants will receive 100 ml of saline alone. Group 2: Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assuta Ashdod Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469203
- Sponsor's protocol ID
- 0127-23-AAA
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin Effectiveness in First Trimester Dilatation and Curettage
- ClinicalTrials.gov ID
- NCT06469203
- Acronym / sponsor ID
- 0127-23-AAA
- Conditions
- Missed Abortion
- Keywords
- missed abortion, vaginal bleeding, dilation and curretage, pregnancy termination, oxytocin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assuta Ashdod HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Jun 2024 (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 this study is to investigate the impact of oxytocin on perioperative blood loss during the D\&C procedure, as well as to assess early and late complications associated with it's use.
Detailed description
Study Design
This study is a prospective randomized placebo-controlled double-blind trial. Women undergoing dilation and curettage, who meet the eligibility criteria for the study, will be divided into two groups. They will receive the assigned medication at the beginning of the procedure, after cervical dilation but before using suction curettage.
Group 1: Participants will receive 100 ml of saline alone. Group 2: Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.
The medication bags will be prepared by the Assuta Ashdod University Hospital Pharmacy, coded with serial numbers, and randomized using computerized software. Both the investigators and patients will remain unaware of the composition of the distension medium to ensure blinding.
A total of 160 patients will be included in the sample size resulting in a net total of 80 patients per group as described below. Patients who choose to withdraw from the study will still be analyzed as intention-to-treat patients.
Inclusion Criteria:
All patients admitted to the OBGYN Assuta Ashdod Hospital for elective surgical termination of pregnancy due to missed miscarriages in the first trimester, with gestational age range of 6.0 to 11.6 weeks.
Patients aged 18 years and older who are capable to provide informed consent.
Exclusion criteria
- individual intolerance to oxytocin
- mullerian anomalies
- Fibroid uterus
- thrombophilia or coagulation disorders
- cardiovascular disease
Primary outcome
Perioperative Blood Loss Assessment:
We will assess perioperative blood loss by:
- Measuring the content collected in the vacuum apparatus after the procedure.
- Recording hemoglobin and hematocrit levels prior to the procedure.
- Measuring hemoglobin and hematocrit levels immediately after the procedure.
- Monitoring hemoglobin and hematocrit levels two weeks post-procedure.
Secondary outcomes
-perioperative complications according to the Dindo-Clavien scale
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Women undergoing dilation and curettage, who meet the eligibility criteria for the study, will be divided into two groups. They will receive the assigned medication at the beginning of the procedure, after cervical dilation but before using suction curettage. Group 1: Participants will receive 100 ml of saline alone. Group 2: Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Sodium Chloride 0.9% InjParticipants will receive 100 ml of saline alone. |
| Oxytocin | Experimental | Drug: Oxytocin, Drug: Sodium Chloride 0.9% InjParticipants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients admitted to the OBGYN Assuta Ashdod Hospital for elective surgical termination of pregnancy due to missed miscarriages in the first trimester, with gestational age range of 6.0 to 11.6 weeks.
- Patients aged 18 years and older who are capable to provide informed consent.
Key exclusion criteria (5 listed)
- individual intolerance to oxytocin
- mullerian anomalies
- Fibroid uterus
- thrombophilia or coagulation disorders
- cardiovascular disease
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 |
|---|---|---|
| OxytocinWomen undergoing dilation and curettage, who meet the eligibility criteria for the study, will be divided into two groups. They will receive the assigned medication at the beginning of the procedure, after cervical dilation but before using suction curettage. Group 1: Participants will receive 100 ml of saline alone. Group 2: Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline. | Drug | Oxytocin |
| Sodium Chloride 0.9% InjWomen undergoing dilation and curettage, who meet the eligibility criteria for the study, will be divided into two groups. They will receive the assigned medication at the beginning of the procedure, after cervical dilation but before using suction curettage. Group 1: Participants will receive 100 ml of saline alone. Group 2: Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline. | Drug | Oxytocin, Placebo |
Primary outcome
Perioperative Blood Loss Assessment
Time frame: 14 days
We will assess perioperative blood loss by: * Measuring the content collected in the vacuum apparatus after the procedure. * Recording hemoglobin and hematocrit levels prior to the procedure. * Measuring hemoglobin and hematocrit levels immediately after the procedure. * Monitoring hemoglobin and hematocrit levels two weeks post-procedure.
1 secondary outcome
perioperative complications according to the Dindo-Clavien scale
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin and Sodium Chloride 0.9% Inj in people with Missed Abortion, run by Assuta Ashdod Hospital.
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 2 inclusion and 5 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 13 Aug 2024. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Blood Loss Assessment (time frame: 14 days). 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 13 Aug 2024.