Preterm DeliveryNCT02059304
Prediction of Preterm Deliveries by Cervical Length Measurement With Embryo Transfer Catheter in ICSI Patients
A study testing Measurement of cervical length with embryo transfer catheter in people with Preterm Delivery, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the potential value of cervical length (CL) measurement with embryo transfer catheter in the prediction of spontaneous preterm deliveries in intracytoplasmic sperm injection (ICSI) cycles. Preterm birth is the leading cause of perinatal death and handicap in children. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Delivery
- What is being tested?
- Measurement of cervical length with embryo transfer catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2012to Jul 2014
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women resulting from ICSI treatment at assisted reproduction center, Acibadem Kayseri Hospital, Turkey.
Who cannot join
- missing outcome data, multiple pregnancies, miscarriages during the first trimester, cigarette smoking, PTD history, progesterone use after 12 weeks, cerclage performed, termination (iatrogenic delivery) and PTDs due to preeclampsia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Cervical Length Measurement With Embryo Transfer Catheter Predict Preterm Deliveries in ICSI Patients?
The aim of this study is to examine the potential value of cervical length (CL) measurement with embryo transfer catheter in the prediction of spontaneous preterm deliveries in intracytoplasmic sperm injection (ICSI) cycles.
Preterm birth is the leading cause of perinatal death and handicap in children. It is clear that ICSI pregnancies are at high risk groupfor preterm delivery (PTD). In singletons there is an estimated two-fold increased risk following ICSI.
Read more
CL measurement with ultrasound in mid-trimester (22-24 weeks) is the best method for the prediction of PTD: The shorter the CL, the higher risk of PTD. Recent evidence suggests that at first trimester (11-13 weeks), the risk for PTD is inversely related to CL. It has been shown that the measurement of CL on pregnancy is an effective method for identification of the group at high risk for PTD.
In embryo transfer, catheter is placed the through cervical canal. The method we will use in this study, CL measurement with transfer catheter, will give more precise results than measurement with ultrasound.
No study has been performed to evaluate the prediction of PTD by analyzing measurements of CL, preconceptionally. Our study will be the first in this topic.
There is a certain disadvantage of measuring CL during pregnancy: The effectiveness of prophylactic administrations (progesterone, cervical cerclage etc.) may be inversely related to the gestation at which treatment is initiated. If we know the risk of PTD before gestation, single embryo transfer will be preferred to avoid from multiple pregnancies that also increase the relative risk of PTD, in ICSI pregnancies.
Read the detailed description
Cervical length measurement protocol: The physician inserted a sterile Collin vaginal speculum; the cervix was exposed and gently cleaned with sterile gauze pads. Cervical mucus was gently removed with a syringe if abundant. A nurse concomitantly performed transabdominal ultrasound scan. Estimated cervical length is determined before transfer procedure. The Sure View Wallace Embryo Replacement Catheter (No. CE118; Smith Medical, Hythe, Kent, UK). There are marked lines on the surface of catheter that show distances to half centimeters. The catheter has a sliding guide fixed at external cervical os. Correct position of the catheter is replaced guide on external os, and guide's endpoint is on internal cervical os. In relation to the internal os was verified on the scan. If required, re-fixation of sliding guide to external os will also be performed. After loading embryos, the length between the guide and the end of catheter will be noted.
Data collection protocol: We will obtain data on pregnancy outcome from the hospital computerized records or the records from family practitioners of the women. We will record birth weeks as major outcome. The obstetric records of all patients will be examined to determine whether any exclusion criteria are present.
- Conditions
- Preterm Delivery
- Being tested
- Measurement of cervical length with embryo transfer catheter
- Keywords
- cervical length, prediction of preterm delivery
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of cervical length with embryo transfer catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Preterm Delivery | Other | Preterm Delivery: Births before the completion of 37 weeks' of gestation. Receives: Device: Measurement of cervical length with embryo transfer catheter |
| Term Delivery | Other | Term Delivery: Births after the completion of 37 weeks' of gestation. Receives: Device: Measurement of cervical length with embryo transfer catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery week
Measured: Due to the pregnancy period ( maximum 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startJan 2012
- Primary completionApr 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm DeliveryStudies of the same condition, open and under way.
- More trials run by Acibadem 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 N/A
- Primary purpose
- Screening
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turgut Aydın, Acibadem University
- Investigators
- Turgut Aydin, Principal investigator, Acıbadem Kayseri Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059304
- Sponsor's protocol ID
- CLM PrDelivery Study
- Status last verified
- Dec 2014
- First submitted
- 7 Feb 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Cervical Length Measurement With Embryo Transfer Catheter Predict Preterm Deliveries in ICSI Patients?
- ClinicalTrials.gov ID
- NCT02059304
- Acronym / sponsor ID
- CLM PrDelivery Study
- Conditions
- Preterm Delivery
- Keywords
- cervical length, prediction of preterm delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Feb 2014 (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.
The aim of this study is to examine the potential value of cervical length (CL) measurement with embryo transfer catheter in the prediction of spontaneous preterm deliveries in intracytoplasmic sperm injection (ICSI) cycles.
Preterm birth is the leading cause of perinatal death and handicap in children. It is clear that ICSI pregnancies are at high risk groupfor preterm delivery (PTD). In singletons there is an estimated two-fold increased risk following ICSI.
CL measurement with ultrasound in mid-trimester (22-24 weeks) is the best method for the prediction of PTD: The shorter the CL, the higher risk of PTD. Recent evidence suggests that at first trimester (11-13 weeks), the risk for PTD is inversely related to CL. It has been shown that the measurement of CL on pregnancy is an effective method for identification of the group at high risk for PTD.
In embryo transfer, catheter is placed the through cervical canal. The method we will use in this study, CL measurement with transfer catheter, will give more precise results than measurement with ultrasound.
No study has been performed to evaluate the prediction of PTD by analyzing measurements of CL, preconceptionally. Our study will be the first in this topic.
There is a certain disadvantage of measuring CL during pregnancy: The effectiveness of prophylactic administrations (progesterone, cervical cerclage etc.) may be inversely related to the gestation at which treatment is initiated. If we know the risk of PTD before gestation, single embryo transfer will be preferred to avoid from multiple pregnancies that also increase the relative risk of PTD, in ICSI pregnancies.
Detailed description
Cervical length measurement protocol: The physician inserted a sterile Collin vaginal speculum; the cervix was exposed and gently cleaned with sterile gauze pads. Cervical mucus was gently removed with a syringe if abundant. A nurse concomitantly performed transabdominal ultrasound scan. Estimated cervical length is determined before transfer procedure. The Sure View Wallace Embryo Replacement Catheter (No. CE118; Smith Medical, Hythe, Kent, UK). There are marked lines on the surface of catheter that show distances to half centimeters. The catheter has a sliding guide fixed at external cervical os. Correct position of the catheter is replaced guide on external os, and guide's endpoint is on internal cervical os. In relation to the internal os was verified on the scan. If required, re-fixation of sliding guide to external os will also be performed. After loading embryos, the length between the guide and the end of catheter will be noted.
Data collection protocol: We will obtain data on pregnancy outcome from the hospital computerized records or the records from family practitioners of the women. We will record birth weeks as major outcome. The obstetric records of all patients will be examined to determine whether any exclusion criteria are present.
Study design
- Primary purpose
- Screening
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm Delivery | Other | Device: Measurement of cervical length with embryo transfer catheterPreterm Delivery: Births before the completion of 37 weeks' of gestation. |
| Term Delivery | Other | Device: Measurement of cervical length with embryo transfer catheterTerm Delivery: Births after the completion of 37 weeks' of gestation. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women resulting from ICSI treatment at assisted reproduction center, Acibadem Kayseri Hospital, Turkey.
Key exclusion criteria (1 listed)
- missing outcome data, multiple pregnancies, miscarriages during the first trimester, cigarette smoking, PTD history, progesterone use after 12 weeks, cerclage performed, termination (iatrogenic delivery) and PTDs due to preeclampsia
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 |
|---|---|---|
| Measurement of cervical length with embryo transfer catheter | Device | Preterm Delivery, Term Delivery |
Primary outcome
Delivery week
Time frame: Due to the pregnancy period ( maximum 9 months)
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 23 Dec 2014.
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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.
Turgut Aydin principal investigator
Acıbadem Kayseri Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of cervical length with embryo transfer catheter in people with Preterm Delivery, run by Acibadem 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 1 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 23 Dec 2014. 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.
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?
Delivery week (time frame: Due to the pregnancy period ( maximum 9 months)). 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 23 Dec 2014.