Sexual IntercourseAchourPrtcolNCT06850467
Sexual Intercourse on Spontaneous Onset of Labor
A study testing Sexual intercourse protocol in people with Sexual Intercourse and Spontaneous Labor, run by Faculty of Medicine of Tunis at 1 site in Tunisia.
Trial summary
Women included in our study were recruited for a randomized trial on the effect of sexual intercourse to promote the onset of spontaneous labor. For this analysis, our sample was divided into two groups by randomization. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Sexual Intercourse, Spontaneous Labor
- What is being tested?
- Sexual intercourse protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteTunisia
- Study dates
- 24 Sep 2021to 24 Feb 2023
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- We included pregnant women (primiparous or multiparous) who presented to the perinatal consultation of the maternity and neonatology center of Tunis. Their pregnancies are evolving singleton, low risk, with intact membranes and cephalic presentation.
Who cannot join
- The non-inclusion criteria were high-risk pregnancies:
- pregnancy pathologies: pregnancy-induced hypertension, pre-eclampsia, gestational diabetes, pregnancy-induced cholestasis, IUGR.
- maternal pathologies: epilepsy, type 1 or 2 diabetes.
- contraindications to vaginal delivery: placenta previa or accreta, history of two (or more) cesarean sections, breech or transverse presentation.
- hospitalizations and/or increased monitoring during pregnancy related to a threat of premature delivery, undetermined bleeding, sexually transmitted diseases, fetal pathologies and/or malformations.
- Patients who did not follow the protocol for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Sexual Intercourse on Spontaneous Onset of Labor
Women included in our study were recruited for a randomized trial on the effect of sexual intercourse to promote the onset of spontaneous labor. For this analysis, our sample was divided into two groups by randomization. The first group (experimental) followed the protocol (sexual intercourse 1 day out of 2 alternating with nipple stimulation alone for 15 minutes three times a day) for 2 weeks. In the control group, sexual relations were neither encouraged nor discouraged. Spontaneous labor prior to the date of scheduled labor induction was the primary outcome. We consider that the result is statistically significant differences when P < 0.05.
Read the detailed description
Participants comprised pregnant women who were receiving prenatal care at the Maternity and Neonatology Center in Tunis (CMNT). This study was a quasi-experimental, comparative, longitudinal, prospective, and monocentric over one year, from September 24, 2021, to September 24, 2022.
Women in the study had to be aged between 18 and 45 years and had to be with uncomplicated singleton pregnancies with gestational age of 37 weeks and above, at low risk for complication, with intact membranes, and in cephalic presentation. Exclusion criteria were pregestational or gestational hypertension, preeclampsia, gestational diabetes, epilepsy in the mother, type 1 or 2 diabetes, contraindications to vaginal delivery, any type of hospitalization, increased surveillance due to suspicion of preterm labor, unexplained vaginal bleeding, sexually transmitted disease, or fetal anomalies.
The study involved pregnant women who were randomly assigned to two groups. The protocol involved engaging in sexual intercourse and nipple stimulation 3 times per day for two consecutive weeks with the consecutive days of sexual intercourse and days of nipple stimulation being different. Patients documented their coital activities as well as the frequency of orgasms in their daily journal. There were no prohibitions regarding or promotions of sexual activities for the control group. The main outcome was the onset of labor, which was defined as the presence of effective uterine contraction with changes of the cervix (Bishop score > 5) without using the induction treatments during protocol time or until 41 weeks of pregnancy.
The subjects were divided into experimental and control groups using simple random sampling. To eliminate group-bias during the allocation, a computer assigned a sequence of random numbers to all the participants. To eliminate selection bias, allocation concealment was ensured by using sequentially numbered, sealed, opaque envelopes which were prepared by an otherwise unrelated third party. Age and parity were considered for stratification of cases and controls to have relatively equal distribution across the groups.
Quantitative data were obtained from the women through self-administered questionnaires which focused on sexual activity during pregnancy and at term. A chi-square test was carried out to determine if there is a significant relationship between sexual intercourse and the incidence of spontaneous onset of labor. Data analysis was performed using SPSS 21 stats software, with a level of significance set at 0.05.
Both the study aim, and protocol were approved by the ethics committee of the Maternity and Neonatology center of Tunis. Informed consent was obtained from all participants. Participants' anonymity and data confidentiality were upheld throughout the study.
- Conditions
- Sexual Intercourse, Spontaneous Labor
- Being tested
- Sexual intercourse protocol
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual intercourse protocolBehavioural
The study involved pregnant women who were randomly assigned to 2 groups. The protocol involved engaging in sexual intercourse and nipple stimulation 3 times per day for two consecutive weeks with the consecutive days of sexual intercourse and days of nipple stimulation being different. Patients documented their coital activities as well as the frequency of orgasms in their daily journal. There were no prohibitions regarding or promotions of sexual activities for the control group. The main outcome was the onset of labor, which was defined as the presence of effective uterine contraction with changes of the cervix (Bishop score > 5) without using the induction treatments during protocol time or until 41 weeks of pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Sexual intercourse protocol | Experimental | Our sample was divided into 2 groups by randomization. The first group (interventional) followed the protocol for 2 weeks. These women were asked to keep a daily diary to record coitus and orgasm activities: the rhythm of sexual intercourse, the nature of the intercourse which must be complete and without a condom. Receives: Behavioral: Sexual intercourse protocol |
| Control group | No intervention | In the control group, sexual intercourse was neither encouraged nor discouraged. |
What is being measured
The primary outcome is the main question the study is designed to answer.
spontaneous onset of labor
The judgment criterion is the spontaneous onset of labor defined by effective uterine contractions leading to cervical modification (a favorable Bishop score, i.e. greater than 5), and without resorting to treatment (prepedil gel, maturation by probe, cytotec, etc.) during the protocol (during the 15 days of the protocol) or after the end of the protocol and up to 41 weeks.
Measured: the spontaneous onset of laborduring the protocol (during the 15 days of the protocol) or after the end of the protocol and up to 41 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start24 Sep 2021
- Primary completion24 Sep 2022
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Sexual IntercourseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine of Tunis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Achour Radhouane, Faculty of Medicine of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850467
- Sponsor's protocol ID
- T00002515
- Acronym
- AchourPrtcol
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Goodlin RC, Keller DW, Raffin M. Orgasm during late pregnancy. Possible deleterious effects. Obstet Gynecol. 1971 Dec;38(6):916-20. No abstract available.
PubMed 5125443Tomlinson AJ, Colliver D, Nelson J, Jackson F. Does sexual intercourse at term influence the onset of labour? A survey of attitudes of patients and their partners. J Obstet Gynaecol. 1999 Sep;19(5):466-8. doi: 10.1080/01443619964210.
PubMed 15512366Singh N, Tripathi R, Mala YM, Yedla N. Breast stimulation in low-risk primigravidas at term: does it aid in spontaneous onset of labour and vaginal delivery? A pilot study. Biomed Res Int. 2014;2014:695037. doi: 10.1155/2014/695037. Epub 2014 Nov 27.
PubMed 25525601Di Lieto A, Miranda L, Ardito P, Favale P, Albano G. Changes in the Bishop score induced by manual nipple stimulation. A cross-over randomized study. Clin Exp Obstet Gynecol. 1989;16(1):26-9.
PubMed 2713990Adewole IF, Franklin O, Matiluko AA. Cervical ripening and induction of labour by breast stimulation. Afr J Med Med Sci. 1993 Dec;22(4):81-5.
PubMed 7839936Salmon YM, Kee WH, Tan SL, Jen SW. Cervical ripening by breast stimulation. Obstet Gynecol. 1986 Jan;67(1):21-4.
PubMed 3940333Kurt B, Demirel G, Caglayan IS, Doganer A. The Effect on the Birth Process of Endogenous Oxytocin Release Via Coitus at Home in Pregnant Women in the Latent Phase. Z Geburtshilfe Neonatol. 2023 Apr;227(2):134-140. doi: 10.1055/a-2019-5031. Epub 2023 Feb 20.
PubMed 36808611Foumane P, Mboudou ET, Sama JD, Baba S, Enama Mbatsogo BA, Ngwana L. Sexual activity during pregnancy and prognosis of labor in Cameroonian women: a cohort study. J Matern Fetal Neonatal Med. 2014 Sep;27(13):1305-8. doi: 10.3109/14767058.2013.856412. Epub 2013 Nov 13.
PubMed 24134484Castro C, Afonso M, Carvalho R, Clode N, Graca LM. Effect of vaginal intercourse on spontaneous labor at term: a randomized controlled trial. Arch Gynecol Obstet. 2014 Dec;290(6):1121-5. doi: 10.1007/s00404-014-3343-0. Epub 2014 Jul 18.
PubMed 25033717Carbone L, De Vivo V, Saccone G, D'Antonio F, Mercorio A, Raffone A, Arduino B, D'Alessandro P, Sarno L, Conforti A, Maruotti GM, Alviggi C, Zullo F. Sexual Intercourse for Induction of Spontaneous Onset of Labor: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Sex Med. 2019 Nov;16(11):1787-1795. doi: 10.1016/j.jsxm.2019.08.002. Epub 2019 Sep 11.
PubMed 31521572Tan PC, Yow CM, Omar SZ. Effect of coital activity on onset of labor in women scheduled for labor induction: a randomized controlled trial. Obstet Gynecol. 2007 Oct;110(4):820-6. doi: 10.1097/01.AOG.0000267201.70965.ec.
PubMed 17906015Tan PC, Yow CM, Omar SZ. Coitus and orgasm at term: effect on spontaneous labour and pregnancy outcome. Singapore Med J. 2009 Nov;50(11):1062-7.
PubMed 19960160Grivell RM, Reilly AJ, Oakey H, Chan A, Dodd JM. Maternal and neonatal outcomes following induction of labor: a cohort study. Acta Obstet Gynecol Scand. 2012 Feb;91(2):198-203. doi: 10.1111/j.1600-0412.2011.01298.x. Epub 2011 Nov 15.
PubMed 21995778Kiesewetter B, Lehner R. Maternal outcome monitoring: induction of labor versus spontaneous onset of labor-a retrospective data analysis. Arch Gynecol Obstet. 2012 Jul;286(1):37-41. doi: 10.1007/s00404-012-2239-0.
PubMed 22298204Christensson K, Nilsson BA, Stock S, Matthiesen AS, Uvnas-Moberg K. Effect of nipple stimulation on uterine activity and on plasma levels of oxytocin in full term, healthy, pregnant women. Acta Obstet Gynecol Scand. 1989;68(3):205-10. doi: 10.3109/00016348909020990.
PubMed 2618602
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sexual Intercourse on Spontaneous Onset of Labor
- ClinicalTrials.gov ID
- NCT06850467
- Acronym / sponsor ID
- AchourPrtcol / T00002515
- Conditions
- Sexual Intercourse, Spontaneous Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Faculty of Medicine of TunisUniversity, hospital or other
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 24 Sep 2022 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 27 Feb 2025 (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.
Women included in our study were recruited for a randomized trial on the effect of sexual intercourse to promote the onset of spontaneous labor. For this analysis, our sample was divided into two groups by randomization. The first group (experimental) followed the protocol (sexual intercourse 1 day out of 2 alternating with nipple stimulation alone for 15 minutes three times a day) for 2 weeks. In the control group, sexual relations were neither encouraged nor discouraged. Spontaneous labor prior to the date of scheduled labor induction was the primary outcome. We consider that the result is statistically significant differences when P < 0.05.
Detailed description
Participants comprised pregnant women who were receiving prenatal care at the Maternity and Neonatology Center in Tunis (CMNT). This study was a quasi-experimental, comparative, longitudinal, prospective, and monocentric over one year, from September 24, 2021, to September 24, 2022.
Women in the study had to be aged between 18 and 45 years and had to be with uncomplicated singleton pregnancies with gestational age of 37 weeks and above, at low risk for complication, with intact membranes, and in cephalic presentation. Exclusion criteria were pregestational or gestational hypertension, preeclampsia, gestational diabetes, epilepsy in the mother, type 1 or 2 diabetes, contraindications to vaginal delivery, any type of hospitalization, increased surveillance due to suspicion of preterm labor, unexplained vaginal bleeding, sexually transmitted disease, or fetal anomalies.
The study involved pregnant women who were randomly assigned to two groups. The protocol involved engaging in sexual intercourse and nipple stimulation 3 times per day for two consecutive weeks with the consecutive days of sexual intercourse and days of nipple stimulation being different. Patients documented their coital activities as well as the frequency of orgasms in their daily journal. There were no prohibitions regarding or promotions of sexual activities for the control group. The main outcome was the onset of labor, which was defined as the presence of effective uterine contraction with changes of the cervix (Bishop score > 5) without using the induction treatments during protocol time or until 41 weeks of pregnancy.
The subjects were divided into experimental and control groups using simple random sampling. To eliminate group-bias during the allocation, a computer assigned a sequence of random numbers to all the participants. To eliminate selection bias, allocation concealment was ensured by using sequentially numbered, sealed, opaque envelopes which were prepared by an otherwise unrelated third party. Age and parity were considered for stratification of cases and controls to have relatively equal distribution across the groups.
Quantitative data were obtained from the women through self-administered questionnaires which focused on sexual activity during pregnancy and at term. A chi-square test was carried out to determine if there is a significant relationship between sexual intercourse and the incidence of spontaneous onset of labor. Data analysis was performed using SPSS 21 stats software, with a level of significance set at 0.05.
Both the study aim, and protocol were approved by the ethics committee of the Maternity and Neonatology center of Tunis. Informed consent was obtained from all participants. Participants' anonymity and data confidentiality were upheld throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sexual intercourse protocol | Experimental | Behavioral: Sexual intercourse protocolOur sample was divided into 2 groups by randomization. The first group (interventional) followed the protocol for 2 weeks. These women were asked to keep a daily diary to record coitus and orgasm activities: the rhythm of sexual intercourse, the nature of the intercourse which must be complete and without a condom. |
| Control group | No intervention | –In the control group, sexual intercourse was neither encouraged nor discouraged. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- We included pregnant women (primiparous or multiparous) who presented to the perinatal consultation of the maternity and neonatology center of Tunis. Their pregnancies are evolving singleton, low risk, with intact membranes and cephalic presentation.
Key exclusion criteria (6 listed)
- The non-inclusion criteria were high-risk pregnancies:
- Patients who did not follow the protocol for any reason.
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 |
|---|---|---|
| Sexual intercourse protocolThe study involved pregnant women who were randomly assigned to 2 groups. The protocol involved engaging in sexual intercourse and nipple stimulation 3 times per day for two consecutive weeks with the consecutive days of sexual intercourse and days of nipple stimulation being different. Patients documented their coital activities as well as the frequency of orgasms in their daily journal. There were no prohibitions regarding or promotions of sexual activities for the control group. The main outcome was the onset of labor, which was defined as the presence of effective uterine contraction with changes of the cervix (Bishop score > 5) without using the induction treatments during protocol time or until 41 weeks of pregnancy. | Behavioural | Sexual intercourse protocol |
Primary outcome
spontaneous onset of labor
Time frame: the spontaneous onset of laborduring the protocol (during the 15 days of the protocol) or after the end of the protocol and up to 41 weeks.
The judgment criterion is the spontaneous onset of labor defined by effective uterine contractions leading to cervical modification (a favorable Bishop score, i.e. greater than 5), and without resorting to treatment (prepedil gel, maturation by probe, cytotec, etc.) during the protocol (during the 15 days of the protocol) or after the end of the protocol and up to 41 weeks.
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 27 Feb 2025.
- Background: PubMed 5125443Goodlin RC, Keller DW, Raffin M. Orgasm during late pregnancy. Possible deleterious effects. Obstet Gynecol. 1971 Dec;38(6):916-20. No abstract available.
- Background: PubMed 15512366Tomlinson AJ, Colliver D, Nelson J, Jackson F. Does sexual intercourse at term influence the onset of labour? A survey of attitudes of patients and their partners. J Obstet Gynaecol. 1999 Sep;19(5):466-8. doi: 10.1080/01443619964210.
- Background: PubMed 25525601Singh N, Tripathi R, Mala YM, Yedla N. Breast stimulation in low-risk primigravidas at term: does it aid in spontaneous onset of labour and vaginal delivery? A pilot study. Biomed Res Int. 2014;2014:695037. doi: 10.1155/2014/695037. Epub 2014 Nov 27.
- Background: PubMed 2713990Di Lieto A, Miranda L, Ardito P, Favale P, Albano G. Changes in the Bishop score induced by manual nipple stimulation. A cross-over randomized study. Clin Exp Obstet Gynecol. 1989;16(1):26-9.
- Background: PubMed 7839936Adewole IF, Franklin O, Matiluko AA. Cervical ripening and induction of labour by breast stimulation. Afr J Med Med Sci. 1993 Dec;22(4):81-5.
- Background: PubMed 3940333Salmon YM, Kee WH, Tan SL, Jen SW. Cervical ripening by breast stimulation. Obstet Gynecol. 1986 Jan;67(1):21-4.
- Background: PubMed 36808611Kurt B, Demirel G, Caglayan IS, Doganer A. The Effect on the Birth Process of Endogenous Oxytocin Release Via Coitus at Home in Pregnant Women in the Latent Phase. Z Geburtshilfe Neonatol. 2023 Apr;227(2):134-140. doi: 10.1055/a-2019-5031. Epub 2023 Feb 20.
- Background: PubMed 24134484Foumane P, Mboudou ET, Sama JD, Baba S, Enama Mbatsogo BA, Ngwana L. Sexual activity during pregnancy and prognosis of labor in Cameroonian women: a cohort study. J Matern Fetal Neonatal Med. 2014 Sep;27(13):1305-8. doi: 10.3109/14767058.2013.856412. Epub 2013 Nov 13.
- Background: PubMed 25033717Castro C, Afonso M, Carvalho R, Clode N, Graca LM. Effect of vaginal intercourse on spontaneous labor at term: a randomized controlled trial. Arch Gynecol Obstet. 2014 Dec;290(6):1121-5. doi: 10.1007/s00404-014-3343-0. Epub 2014 Jul 18.
- Background: PubMed 31521572Carbone L, De Vivo V, Saccone G, D'Antonio F, Mercorio A, Raffone A, Arduino B, D'Alessandro P, Sarno L, Conforti A, Maruotti GM, Alviggi C, Zullo F. Sexual Intercourse for Induction of Spontaneous Onset of Labor: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Sex Med. 2019 Nov;16(11):1787-1795. doi: 10.1016/j.jsxm.2019.08.002. Epub 2019 Sep 11.
- Background: PubMed 17906015Tan PC, Yow CM, Omar SZ. Effect of coital activity on onset of labor in women scheduled for labor induction: a randomized controlled trial. Obstet Gynecol. 2007 Oct;110(4):820-6. doi: 10.1097/01.AOG.0000267201.70965.ec.
- Background: PubMed 19960160Tan PC, Yow CM, Omar SZ. Coitus and orgasm at term: effect on spontaneous labour and pregnancy outcome. Singapore Med J. 2009 Nov;50(11):1062-7.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual intercourse protocol in people with Sexual Intercourse and Spontaneous Labor, run by Faculty of Medicine of Tunis at 1 site in Tunisia.
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 6 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 27 Feb 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 Tunisia. 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?
spontaneous onset of labor (time frame: the spontaneous onset of laborduring the protocol (during the 15 days of the protocol) or after the end of the protocol and up to 41 weeks.). 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 NCT06850467, which also lists 17 linked publications.
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 27 Feb 2025.