Post-AbortionNCT03907735
Oxytocin Receptor Expression in Pregnancy
An observational study of Post-Abortion and Hemorrhage, Obstetric, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This study aims to determine when during gestation oxytocin receptor (OXTR) expression increases in the myometrium, which will contribute new insight to the management of obstetric hemorrhage and our understanding of normal and abnormal labor. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-Abortion, Hemorrhage, Obstetric
- What is being tested?
- Myometrial tissue sample collection
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2019to Aug 2025
- 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
- Healthy volunteers accepted
- Adult
Study population: This is a study of reproductive age women over 18 years of age being performed at Oregon Health \& Science University (OHSU) in Portland, OR. It will include subjects who present for pre-operative appointments in our outpatient Center for Women's Health Family Planning Clinic and OHSU Labor and Delivery.
Who may be able to join
- Women age 18-50
- Gestational age 14-26 weeks; or 6-13 weeks, 37-42 weeks, or non-pregnant (controls)
- Undergoing another planned surgical procedure with anesthesia (suction D\&C, D\&E, gravid hysterectomy, cesarean section, or laparoscopic tubal ligation)
- Able to give informed consent in English or Spanish
Who cannot join
- To optimize biopsy safety, we will exclude patients with anticipated difficult cases, that have additional risks of hemorrhage, or those with features that limit ultrasound visualization.
- Increased risk of hemorrhage:
- Anemia (Hgb < 9)
- Anticoagulation, bleeding disorder, or coagulopathy
- Multiple gestation
- Infection or sepsis
Show all 12Show fewer
- For ultrasound-guided procedures:
- Obese, BMI ≥ 40
- History of ≥2 cesarean sections
- Large fibroids or uterine anomalies obstructing view
- Other poor visualization
- Thin myometrium < 1cm
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Oxytocin Receptor Expression in Pregnancy: When Does it Turn on
This study aims to determine when during gestation oxytocin receptor (OXTR) expression increases in the myometrium, which will contribute new insight to the management of obstetric hemorrhage and our understanding of normal and abnormal labor.
Read the detailed description
In this descriptive study, we will obtain myometrial tissue samples by core needle biopsy under ultrasound guidance in anesthetized women immediately following surgical abortion and from controls, all of whom are undergoing a separate planned obstetric/gynecologic surgery. Tissue studies will be performed on these biopsy samples to examine oxytocin receptor expression and function.
- Conditions
- Post-Abortion, Hemorrhage, Obstetric
- Being tested
- Myometrial tissue sample collection
- Keywords
- Post-abortion hemorrhage, Obstetric hemorrhage, Preterm labor, Abnormal labor, Oxytocin, Oxytocin receptor
- Medical subject headings
- Hemorrhage, Obstetric Labor, Premature, Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myometrial tissue sample collectionOther
Myometrial tissue samples by core needle biopsy under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| 2nd trimester | Second trimester myometrial tissue samples will be collected by core needle biopsy under ultrasound guidance in anesthetized women. Samples will be obtained primarily after second trimester surgical abortions or Dilation and Evacuation (D\&E) procedures as well as after rare gravid hysterectomies or after late second trimester cesarean deliveries. Receives: Other: Myometrial tissue sample collection | |
| Non-pregnant | Myometrial tissue samples will be collected by core needle biopsy under ultrasound guidance in non-pregnant women undergoing gynecologic surgery under anesthesia for laparoscopic tubal ligation. Receives: Other: Myometrial tissue sample collection | |
| 1st trimester | First trimester myometrial tissue samples will be collected by core needle biopsy under ultrasound guidance in anesthetized women. Samples will be obtained after first trimester surgical abortions or suction dilation and curettage (D\&C). Receives: Other: Myometrial tissue sample collection | |
| After term pregnancy (3rd trimester) | Third trimester myometrial tissue samples will be collected by core needle biopsy under ultrasound guidance in anesthetized women. Samples will be obtained at the time of cesarean delivery. Receives: Other: Myometrial tissue sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxytocin receptor expression
Measure of oxytocin receptor expression. Perform quantitative RT-PCR on mRNA extracted from biopsy samples obtained from subjects at the end of their procedure (within 30 minutes).
Measured: 30 minutes
Secondary outcomes (1)
Function of myometrial oxytocin receptor
Assessment of the function of the myometrial oxytocin receptor. Measure intracellular calcium in cultured myometrial cells after activating the receptor with oxytocin from biopsy samples obtained from subjects at the end of their procedure (within 30 minutes).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start3 Jun 2019
- Primary completion22 Aug 2020
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Reid, Oregon Health and Science University
- Investigators
- Jessica Reid, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907735
- Sponsor's protocol ID
- OHSU IRB 19417
- Status last verified
- May 2025
- First submitted
- 5 Apr 2019
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reid JA, Jensen JT, Edelman AB, Han LL, Baldwin MK. A novel technique for transcervical biopsy of the myometriumdagger. Biol Reprod. 2026 May 13;114(5):1765-1771. doi: 10.1093/biolre/ioag069.
PubMed 41920951
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin Receptor Expression in Pregnancy: When Does it Turn on
- ClinicalTrials.gov ID
- NCT03907735
- Acronym / sponsor ID
- OHSU IRB 19417
- Conditions
- Post-Abortion, Hemorrhage, Obstetric
- Keywords
- Post-abortion hemorrhage, Obstetric hemorrhage, Preterm labor, Abnormal labor, Oxytocin, Oxytocin receptor
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 22 Aug 2020 (actual)
- Study completion
- Aug 2025 (estimated)
- First posted
- 9 Apr 2019 (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.
This study aims to determine when during gestation oxytocin receptor (OXTR) expression increases in the myometrium, which will contribute new insight to the management of obstetric hemorrhage and our understanding of normal and abnormal labor.
Detailed description
In this descriptive study, we will obtain myometrial tissue samples by core needle biopsy under ultrasound guidance in anesthetized women immediately following surgical abortion and from controls, all of whom are undergoing a separate planned obstetric/gynecologic surgery. Tissue studies will be performed on these biopsy samples to examine oxytocin receptor expression and function.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2nd trimester | – | Other: Myometrial tissue sample collectionSecond trimester myometrial tissue samples will be collected by core needle biopsy under ultrasound guidance in anesthetized women. Samples will be obtained primarily after second trimester surgical abortions or Dilation and Evacuation (D\&E) procedures as well as after rare gravid hysterectomies or after late second trimester cesarean deliveries. |
| Non-pregnant | – | Other: Myometrial tissue sample collectionMyometrial tissue samples will be collected by core needle biopsy under ultrasound guidance in non-pregnant women undergoing gynecologic surgery under anesthesia for laparoscopic tubal ligation. |
| 1st trimester | – | Other: Myometrial tissue sample collectionFirst trimester myometrial tissue samples will be collected by core needle biopsy under ultrasound guidance in anesthetized women. Samples will be obtained after first trimester surgical abortions or suction dilation and curettage (D\&C). |
| After term pregnancy (3rd trimester) | – | Other: Myometrial tissue sample collectionThird trimester myometrial tissue samples will be collected by core needle biopsy under ultrasound guidance in anesthetized women. Samples will be obtained at the time of cesarean delivery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This is a study of reproductive age women over 18 years of age being performed at Oregon Health \& Science University (OHSU) in Portland, OR. It will include subjects who present for pre-operative appointments in our outpatient Center for Women's Health Family Planning Clinic and OHSU Labor and Delivery.
Key inclusion criteria (4 listed)
- Women age 18-50
- Gestational age 14-26 weeks; or 6-13 weeks, 37-42 weeks, or non-pregnant (controls)
- Undergoing another planned surgical procedure with anesthesia (suction D\&C, D\&E, gravid hysterectomy, cesarean section, or laparoscopic tubal ligation)
- Able to give informed consent in English or Spanish
Key exclusion criteria (12 listed)
- To optimize biopsy safety, we will exclude patients with anticipated difficult cases, that have additional risks of hemorrhage, or those with features that limit ultrasound visualization.
- Anemia (Hgb < 9)
- Anticoagulation, bleeding disorder, or coagulopathy
- Multiple gestation
- Infection or sepsis
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 |
|---|---|---|
| Myometrial tissue sample collectionMyometrial tissue samples by core needle biopsy under ultrasound guidance | Other | 1st trimester, 2nd trimester, After term pregnancy (3rd trimester), Non-pregnant |
Primary outcome
Oxytocin receptor expression
Time frame: 30 minutes
Measure of oxytocin receptor expression. Perform quantitative RT-PCR on mRNA extracted from biopsy samples obtained from subjects at the end of their procedure (within 30 minutes).
1 secondary outcome
Function of myometrial oxytocin receptor
Time frame: 30 minutes
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 31 May 2025.
- Derived from this study: PubMed 41920951Reid JA, Jensen JT, Edelman AB, Han LL, Baldwin MK. A novel technique for transcervical biopsy of the myometriumdagger. Biol Reprod. 2026 May 13;114(5):1765-1771. doi: 10.1093/biolre/ioag069.
- 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.
Jessica Reid, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Abortion and Hemorrhage, Obstetric, run by Oregon Health and Science University at 1 site in United States.
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 4 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 31 May 2025. 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 United States. 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?
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?
Oxytocin receptor expression (time frame: 30 minutes). 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 NCT03907735, which also lists 1 linked publication.
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 31 May 2025.