Labor OnsetNCT00433303
Correlation Between Coital Activity During Pregnancy and Premature Delivery Related to Prostanoid Receptor Polymorphisms
An observational study of Labor Onset and Gravidity, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The purpose of our study is correlate between premature delivery (between week 23-35 of the pregnancy) in women that had intercourse up to 12 hours prior to beginning of labor and polymorphisms in the gene Prostanoid receptor. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Labor Onset, Gravidity
- What is being tested?
- Correlation between early delivery and coital activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 20 to 40 years
- Women only
- Adult
Who may be able to join
- Women who start delivery in weeks 23-35 of pregnancy 12 hours after intercourese.
- Women who come for delivery after week 31 and have not had intercourse during the previous month.
- Women at term who have been sexually active during their pregnancy.
Who cannot join
- Any other women who come in for delivery.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of our study is correlate between premature delivery (between week 23-35 of the pregnancy) in women that had intercourse up to 12 hours prior to beginning of labor and polymorphisms in the gene Prostanoid receptor.
Read the detailed description
During the past years there has been a conflict between different studies regarding the correlation between intercourse during pregnancy and early labor. Brustman et al showed that women that were at a high risk for early delivery and had intercourse and then an early labor had significantly increase uterine activity compared to women at low risk. Petridou et al showed that this risk is significantly higher at week 33 of gestation. However, the Cochrane Library summary leaves the question of correlation between intercourse and early labor unanswered. In Sayle et al's study showed no correlation between early delivery and intercourse. In 2004 Oguma described 3 polymorphisms in the Prostanoid receptor gene. These polymorphisms were correlated to increased activity of smooth muscles of bronchi in asthma. Since this gene is also expressed in the uterine muscles we wanted to determine whether there is a correlation between the three polymorphisms T-549C, C-441T, T-197C, G+1044A and early delivery due to intercourse.
- Brustman LS, Raptoulis M. Langer O, Anyaegbunam A \& Merkatz IR. Changes in the pattern of uterine contractility in relationship to coitus during pregnancies at low and high risk for preterm labor. Obstet Gynecol 1989;73:166-168
- Petridou E, Salvnos H, Skalkidou A, Dessypris N, Moustaki M \& Trichopoulos D. Are there common triggers of preterm deliveries. British J Obst Gynecol 2001;108:598-604)
- Kavanagh J, Kelly AJ \& Thomas J. Sexual intercourse for cervical ripening and induction of labour. The Cochrane Database of Systematic Reviews 2001, Issuse 2.Art. No.:CD003093. DOI: 10.1002/14651858.CD003093
- Sayle AE, Savitz DA, Thorp JM, Hertz-Picciotto I \& Wilcox AJ. Sexual activity during late pregnancy and risk of preterm delivery. Obstet Gynecol 2001;97:283-9)
- Bernal AL. Mechanisms of labour-biochemical aspects. BJOG 2003;110(Supp 20):39-45
- Oguma T, Palmer L, Birden E, Sonna LA, Asano K\& Lilly CM. Role of prostanoid dp receptor variants in susceptibility to asthma. NEJM 2004;351:1752-63
- Conditions
- Labor Onset, Gravidity
- Being tested
- Correlation between early delivery and coital activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Correlation between early delivery and coital activityBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2007 (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 Labor OnsetStudies 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
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Michael Schimmel, Prof., Principal investigator, Neonatology Unit, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433303
- Sponsor's protocol ID
- Intercourse-Prostanoid DP
- Status last verified
- Feb 2007
- First submitted
- 8 Feb 2007
- Last updated
- 9 Feb 2007
- Results posted
- No
Publications
Brustman LE, Raptoulis M, Langer O, Anyaegbunam A, Merkatz IR. Changes in the pattern of uterine contractility in relationship to coitus during pregnancies at low and high risk for preterm labor. Obstet Gynecol. 1989 Feb;73(2):166-8.
PubMed 2911421
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Coital Activity During Pregnancy and Premature Delivery Related to Prostanoid Receptor Polymorphisms
- ClinicalTrials.gov ID
- NCT00433303
- Acronym / sponsor ID
- Intercourse-Prostanoid DP
- Conditions
- Labor Onset, Gravidity
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- First posted
- 9 Feb 2007 (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 purpose of our study is correlate between premature delivery (between week 23-35 of the pregnancy) in women that had intercourse up to 12 hours prior to beginning of labor and polymorphisms in the gene Prostanoid receptor.
Detailed description
During the past years there has been a conflict between different studies regarding the correlation between intercourse during pregnancy and early labor. Brustman et al showed that women that were at a high risk for early delivery and had intercourse and then an early labor had significantly increase uterine activity compared to women at low risk. Petridou et al showed that this risk is significantly higher at week 33 of gestation. However, the Cochrane Library summary leaves the question of correlation between intercourse and early labor unanswered. In Sayle et al's study showed no correlation between early delivery and intercourse. In 2004 Oguma described 3 polymorphisms in the Prostanoid receptor gene. These polymorphisms were correlated to increased activity of smooth muscles of bronchi in asthma. Since this gene is also expressed in the uterine muscles we wanted to determine whether there is a correlation between the three polymorphisms T-549C, C-441T, T-197C, G+1044A and early delivery due to intercourse.
- Brustman LS, Raptoulis M. Langer O, Anyaegbunam A \& Merkatz IR. Changes in the pattern of uterine contractility in relationship to coitus during pregnancies at low and high risk for preterm labor. Obstet Gynecol 1989;73:166-168
- Petridou E, Salvnos H, Skalkidou A, Dessypris N, Moustaki M \& Trichopoulos D. Are there common triggers of preterm deliveries. British J Obst Gynecol 2001;108:598-604)
- Kavanagh J, Kelly AJ \& Thomas J. Sexual intercourse for cervical ripening and induction of labour. The Cochrane Database of Systematic Reviews 2001, Issuse 2.Art. No.:CD003093. DOI: 10.1002/14651858.CD003093
- Sayle AE, Savitz DA, Thorp JM, Hertz-Picciotto I \& Wilcox AJ. Sexual activity during late pregnancy and risk of preterm delivery. Obstet Gynecol 2001;97:283-9)
- Bernal AL. Mechanisms of labour-biochemical aspects. BJOG 2003;110(Supp 20):39-45
- Oguma T, Palmer L, Birden E, Sonna LA, Asano K\& Lilly CM. Role of prostanoid dp receptor variants in susceptibility to asthma. NEJM 2004;351:1752-63
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women who start delivery in weeks 23-35 of pregnancy 12 hours after intercourese.
- Women who come for delivery after week 31 and have not had intercourse during the previous month.
- Women at term who have been sexually active during their pregnancy.
Key exclusion criteria (1 listed)
- Any other women who come in for delivery.
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 |
|---|---|---|
| Correlation between early delivery and coital activity | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2007.
- Background: PubMed 2911421Brustman LE, Raptoulis M, Langer O, Anyaegbunam A, Merkatz IR. Changes in the pattern of uterine contractility in relationship to coitus during pregnancies at low and high risk for preterm labor. Obstet Gynecol. 1989 Feb;73(2):166-8.
Related trials for Labor Onset
Not yet recruitingPhase 4
PROMab Trial: Ampicillin With or Without Gentamicin for Term Prelabour Rupture of Membranes
Rupture of Membranes Prior to Onset of Labor
RecruitingPhase 2
Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial
Labor Onset and Length Abnormalities, First Birth
Recruiting
The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
Labor Dystocia, Labor Complication
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.
Michael Schimmel, Prof. principal investigator
Neonatology Unit, Shaare Zedek Medical Center, Jerusalem, Israel
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 Labor Onset and Gravidity, run by Shaare Zedek Medical Center at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 9 Feb 2007. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Schimmel, Prof. (972-2-6550689, schimmel@New.szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00433303, 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 9 Feb 2007; AzTrials last refreshed its copy on 6 Nov 2026.