Abortion, InducedPhase 4NCT02485444
Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage of Labor After Second-trimester Abortion
A Phase 4 study testing Oxytocin in people with Abortion, Induced and Labor Stage, Third/Drug Effects, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study compares oxytocin infusion to spontaneous follow-up for third-stage of labor at induced mid-trimester abortions. Patients will be randomized to oxytocin infusion or observation with no pharmacologic intervention. Primary outcome of the study is complete abortion rate within two hours of fetal delivery. Read more about this study
- Who is it for?
- Ages 17 to 45 years, women only
- Conditions the study is for
- Abortion, Induced, Labor Stage, Third/Drug Effects, Pregnancy Trimester, Second
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2015to 10 Jun 2016
- Phase
- Phase 4
- 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 17 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- -Women who had mid-trimester termination of pregnancy between 13-24 gestational weeks
Who cannot join
- If fetus and placenta expelled together
- Obstetrical haemorrhage needs intervention
- Known prostaglandin allergy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk Üniversitesi Araştırma Hastanesi
Erzurum, 25240
About this study
Official title: Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage Management After Second-trimester Abortion: A Randomized Clinical Trial
This study compares oxytocin infusion to spontaneous follow-up for third-stage of labor at induced mid-trimester abortions. Patients will be randomized to oxytocin infusion or observation with no pharmacologic intervention. Primary outcome of the study is complete abortion rate within two hours of fetal delivery.
- Conditions
- Abortion, Induced, Labor Stage, Third/Drug Effects, Pregnancy Trimester, Second, Oxytocin/Administration & Dosage
- Being tested
- Oxytocin
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Synpitan, Pitocin
20 IU oxytocin in 500 ml normal saline will be infused 100 ml/h i.v. after fetus is delivered
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | Not described Receives: Drug: Oxytocin |
| Observation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete abortion rate
expulsion of placenta completely without an instrumental assistance within two hours after delivery of fetus
Measured: within 5 minute after placenta delivered
Secondary outcomes (4)
Blood loss estimated by gravimetric method
blood loss will be estimated by gravimetric method
Measured: within 10 minutes after delivery of placenta
Transfusion rate
number of packed red cell units transfused
Measured: Within 7 days of hospitalization
Change in hemoglobin measured by difference in hemoglobin before and 24-hour after abortion
Difference in hemoglobin before and 24-hour after abortion
Measured: 24 hours after delivery of placenta
Placenta delivery time measured by time elapsed until the delivery of the placenta from the delivery of foetus
The time elapsed until the delivery of the placenta from the delivery of foetus
Measured: 5 minute after delivery of placenta
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study start8 Jun 2015
- Primary completion31 May 2016
- Study completion10 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, InducedStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragıp Atakan Al, Ataturk University
- Investigators
- Omer E Yapca, MD, Study chair, Ataturk UniversityRagıp A AL, MD, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485444
- Sponsor's protocol ID
- 2015-80
- Status last verified
- Feb 2023
- First submitted
- 28 Jun 2015
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage Management After Second-trimester Abortion: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02485444
- Acronym / sponsor ID
- 2015-80
- Conditions
- Abortion, Induced, Labor Stage, Third/Drug Effects, Pregnancy Trimester, Second, Oxytocin/Administration & Dosage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 8 Jun 2015 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 10 Jun 2016 (actual)
- First posted
- 30 Jun 2015 (estimated)
- 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.
This study compares oxytocin infusion to spontaneous follow-up for third-stage of labor at induced mid-trimester abortions. Patients will be randomized to oxytocin infusion or observation with no pharmacologic intervention. Primary outcome of the study is complete abortion rate within two hours of fetal delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Drug: Oxytocin |
| Observation | No intervention | – |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- -Women who had mid-trimester termination of pregnancy between 13-24 gestational weeks
Key exclusion criteria (3 listed)
- If fetus and placenta expelled together
- Obstetrical haemorrhage needs intervention
- Known prostaglandin allergy
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 |
|---|---|---|
| OxytocinAlso: Synpitan, Pitocin20 IU oxytocin in 500 ml normal saline will be infused 100 ml/h i.v. after fetus is delivered | Drug | Oxytocin |
Primary outcome
Complete abortion rate
Time frame: within 5 minute after placenta delivered
expulsion of placenta completely without an instrumental assistance within two hours after delivery of fetus
4 secondary outcomes
Blood loss estimated by gravimetric method
Time frame: within 10 minutes after delivery of placenta
Transfusion rate
Time frame: Within 7 days of hospitalization
Change in hemoglobin measured by difference in hemoglobin before and 24-hour after abortion
Time frame: 24 hours after delivery of placenta
Placenta delivery time measured by time elapsed until the delivery of the placenta from the delivery of foetus
Time frame: 5 minute after delivery of placenta
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
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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.
Omer E Yapca, MD study chair
Ataturk University
Ragıp A AL, MD principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxytocin in people with Abortion, Induced and Labor Stage, Third/Drug Effects, run by Ataturk University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete abortion rate (time frame: within 5 minute after placenta delivered). 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 28 Feb 2023.